Medical Device Recalls
MARCQI posts Class I and Class II recalls that involve implantable devices because of the risk to patients. For reference, the definitions of these classes, according to the Food and Drug Administration (FDA), are:
- Class 1 recall: a situation in which there is a reasonable probability that the use of or exposure to a volatile product will cause serious adverse health consequences or death.
- Class 2 recall: a situation in which use of or exposure to a volatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class 3 recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
- Medical Device Safety Alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.
- Correction or Removal: manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health.
2018 Correction or Removal
- Error in labeling.
2018 Class 2 Recalls
- Vanguard Knee System PS Tibial Bearing
- The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
- Vanguard Complete Knee System E1 PS Tibial Bearing
- Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa.
- Biomet Modular Primary Tibial Tray Implants (size 75 mm)
- One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray.
- Stryker Restoris MCK Tibial Baseplate
- Error in labeling. The labeling of the implant box outer label states the correct size of the implant. The patient sticker located inside the outer box states the incorrect size of the implant.
- Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model #00-5850-030-38
- There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.
- Error in labeling.
- These devices are being recalled based on elevated revision rates observed as part of the device manufacturer’s post-market surveillance process.
- The LDPE bag packaging for various highly polished hip and knee implants may adhere to the
highly polished surface, leaving residue or material from the LDPE bag on the implant after it is
removed from the bag.
- Zimmer Biomet VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
- Zimmer Biomet VERSYS 10 INCH BEADED FC REV 15.0X250MM BOWED LT & RT
- Zimmer Biomet VERSYS 10 INCH BEADED FC REV 13.5X250MM BOWED LT and RT
- Zimmer Biomet VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT
- Zimmer Biomet VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK
- Zimmer Biomet VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK
- Zimmer Biomet VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK
- Zimmer Biomet VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK
- Zimmer Biomet CPT 12/14 COCR, SIZE 0, STD
- Zimmer Biomet CPT 12/14 COCR REVISION SIZE 2 180MM
- Zimmer Biomet CPT 12/14 COCR SIZE 1 EXT
- Zimmer Biomet CPT 12/14 COCR Sz 2 Multiple Lot Numbers
- Zimmer Biomet CPT 12_14 COCR Sz 2 STD Multiple Lot Numbers
- Zimmer Biomet BIPOLAR METAL SHELL 48 MM OD
- Zimmer Biomet CPT 12/14 COCR SIZE 2 EXT
- Zimmer Biomet NEXGEN POROUS, HA/TCP, UNCEMENTED FEM & TIB BASEPLATE, SZ C thru G, LT & RT, MINUS
- Zimmer Biomet Nexgen Porous, HA/TCP, Uncemented Fem & Tib Baseplate, SZ C thru G, LT & RT, MINUS, MULTIPLE CAT #S
- Zimmer Biomet NEXGEN POROUS, UNCEMENTED FEMORAL AND TIB BASEPLATE, SZ E & F, LT
- Zimmer Biomet NEXGEN POROUS, HA_TCP, UNCEMENTED FEM & TIB BASEPLATE, SZ C thru G, LT&RT
- Zimmer NexGen LPS Option Fem Comps Sz C thru H
- Zimmer NexGen LPS Fem Comp Sz B thru G
- Zimmer NexGen LPS Fem Comp Sz G, Left
- Zimmer NexGen LPS Precoat Femoral Sz D & E
- Zimmer NEXGEN LPS Flex Precoat Fem Comp, Sz B thru G
- Zimmer NEXGEN LPS Flex Porous Fem Comp, Sz E
- Zimmer NexGen LPS Precoat Femoral Sizes D thru F
- Zimmer NexGen LPS Flex Option Fem Comp
- Zimmer NEXGEN LPS Flex GSF Option, SZ C thru G, LT & RT
- Zimmer NEXGEN LPS Flex GSF Porous Fem, SZ F, RT
- Zimmer NEXGEN CR Flex Option Femoral Minus, Sz C thru G
- Zimmer NEXGEN CR Flex Opt Femoral, Sz C thru G, LT & RT
- Zimmer NEXGEN CR Flex Porous Femoral
- Zimmer NexGen CR Flex GSF Precoat, SZ C thru G, LT & RT
- Zimmer The Natural Knee II Sys Cancellous Structured Titanium Porous Coating
- Zimmer Natural Knee Flex_NexGen CR Flex
- Zimmer Natural Knee Flex GSF NonPorous Fem
- Zimmer Natural Knee Flex GSF Porous Fem
- Zimmer NEXGEN Complete Knee Solution Legacy Posterior Stabilized, Sz H-Right
- Zimmer NEXGEN Complete Knee Solution Legacy Posterior Stabilized, LCCK, Sz C thru F
- Zimmer NEXGEN Complete Knee System Precoat Fem Comp
- Zimmer NEXGEN Knee System CR Option Fem Comp
- Zimmer NEXGEN Complete Knee Solution CR
- Zimmer NEXGEN Knee, SZ 4 thru 8, LT AND RT
- Zimmer PFJ Fem Cemented
- Zimmer PFJ Fem Cemented, SZ 4, RT
- Zimmer Unicomp Knee, SZ B thru F, RT & LT, MED & LAT
- Zimmer Unicomp Knee, RT and LT, SM, REG and LGE
- The products being recalled exceeded the weight previously tested leading to a possibility of
damage to the package and/or a compromised sterile barrier.
- Error in labeling. Wrong device description of the label identifying the implant. The affected lot numbers are being recalled because the device listed on the package may not be correct.
- The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.
- The affected AGC 2000 LP Patella products were overmolded leaving the outside diameter nonconforming to the print dimension.
- Knee implant components (tibial bearings) are labeled with the incorrect size.
- There is a possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. There are Class II Recalls for the following Zimmer Biomet devices:
- Biolox Delta Option Ceramic Heads, 32MM, Model #650-1056
- Ceramic Option Type 1 Taper Sleeve, -6, Model #650-1064
- Echo Bimetric Porous Femoral Hip System, 9×125, Model #192009
- OSS Distal Femoral LT ASSY, 19CM, Model #CP111828
- OSS Distal Femoral RT ASSY, 19CM, Model #CP111817
- OSS Cemented IM Stem 12×150, Model #150366
- Device was distributed with the etching missing from the product:
- Medacta has observed a worldwide occurrence rate of postoperative insert screw backout
of approximately 0.1%:
2017 Class 2 Recalls
- MAKO RIO Robotic-arm
- An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection
- Zimmer Biomet Various Polyethylene Implants
- Sports Med
- Repicci II Tibial Components
- Zimmer Biomet Custom Polyethlylene Implants
- Zimmer Biomet Various Polyethylene Implants- Hips
- Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
- Multiple products including Active Articulation, Biolox Delta Option Head, RingLoc
Field Safety Notice
- Zimmer Biomet – Cementless Oxford Partial Knee Unicompartmental Knee Replacement System
- Biomet UK issued a voluntary field safety corrective action; analysis identified a world wide occurrence of 0.12% of patients experiencing tibial plateau fractures.
- Smith Nephew Inc – Reflection Dead Blow Mallet
- In a small number of cases, cracks that occur in the welds of the head of the mallet have resulted in the escape of some lead beads.
- Exactech Logic Fit Tibial Tamp Head
- Exactech 1.5” Novation Calcar Planer Guide Tip
- Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates (Zimmer Biomet)
- Stryker Instruments Precision Match Head, Precision Round, MIS (minimally invasive surgery) product to remove osseous material during surgical cases. Multiple sizes.
- Stryker Restoris RIO Reamer Handle, Offset, MAKO Rx only
- Handle that is used to hold surgical components during acetabular reaming in MAKO Total Hip Procedures
- Mako RIO THA Application User Guides
- Five AFMEA Riskk Control Measures are missing from the User Guides.
- Vanguard Total Knee, Punch Thru TRL Plates, 63mm, 67mm, 71mm, 75mm, 79mm
- Oxford Knee System Tibial Resector Body Tube & Guides
- Oxford Knee System Femoral Slap Hammer
- Oxford Partial Knee System (in the following sizes):
- Left Medial Tibial Trial Tray Size A
- Left Medial Tibial Trial Tray Size B
- Left Medial Tibial Trial Tray Size C
- Left Medial Tibial Trial Tray Size D
- Left Medial Tibial Trial Tray Size E
- Left Medial Tibial Trial Tray Size F
- Phase 3 Tibial Template L Medial Size B
- Phase 3 Tibial Template L Medial Size C
- Phase 3 Tibial Template R Medial Size A
- Phase 3 Tibial Template R Medial Size B
- Phase 3 Tibial Template R Medial Size C
- Phase 3 Tibial Template R Medial Size D
- Right Medial Tibial Trial Tray Size A
- Right Medial Tibial Trial Tray Size B
- Right Medial Tibial Trial Tray Size C
- Right Medial Tibial Trial Tray Size D
- Right Medial Tibial Trial Tray Size E
- Right Medial Tibial Trial Tray Size F
- Oxford Unicompartmental Knee Phase 3 Shim Size 1
- Oxford Unicompartmental Knee Phase 3 Shim Size 2
- Oxford Unicompartmental Knee Phase 3 Shim Size 3
- Oxford Unicompartmental Knee Phase 3 Tibial Impactor
2016 Class 1 Recalls
2016 Class 2 Recalls
Posted April, 2016
The following Class II Recall Notifications from Zimmer Biomet include a variety of catalog and lot numbers. The reason, cause, and action for each recall can be found in each of the .pdf documents listed here for your reference. A link to the FDA website for each recall is also included at the bottom of each .pdf file. Please review the details to determine any impact to your cases.
The reason, cause, and action for the recalls listed below is as described by the FDA on its website:
Manufacturer Reason for Recall
As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile.
FDA Determined Cause 2
Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:
- Review the notification and ensure that relevant personnel are aware of the contents.
- Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
- Your Zimmer Biomet sales representative will remove the recalled product from your facility.
- Complete and return the attached Certificate of Acknowledgment form to email@example.com.
- If after reviewing this notification you have further questions or concerns please call
Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative
- Zimmer Packaging Recall
- NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3
- SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE
- Stryker Sagittal Blade 18.0X0.97X90MM
- Zimmer Gender Solutions Patellofemoral Joint Prosthesis Milling Handpiece
- Stryker Orthopaedics Patella Assembly Instrument (Scorpio Patella Assembly)
- Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock
- (Stryker) Exeter Rasp/Trial Introducer/Extractor Handle part of the Exeter Femoral Hip System
- Stryker Orthopaedics Trident Constrainer Liner Inserter/Impactor Tip, 22mm, 28mm, and 32mm (sterilization issue)
- Zimmer Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets
- Prelude Patella Femoral Resurfacing Knee System Instrumentation
- Restoris PST Offset Shell Impactor
- Robotic Arm Interactive Orthopedic System (MAKO)
2015 Class 1 Recalls
2015 Class ll Recalls