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 I 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 II 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 III 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.
2018 Class II Recalls
- 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 RT ASSY, 19CM, Model #CP111828
- OSS Distal Femoral RT ASSY, 19CM, Model #CP111817
- OSS Cemented IM Stem 12×150, Model #150366
- PPS RingLoc+ Acetabular Shell, SZ62, Model #11-116062
- Medacta has observed a worldwide occurrence rate of postoperative insert screw backout
of approximately 0.1%.
- Device was distributed with the etching missing from the product.
2017 Class II 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 I Recalls
2016 Class II 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 I Recalls
2015 Class ll Recalls