Device Recall Information

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.

2017 Class II Recalls

July

  • MAKO RIO Robotic-arm
    • An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection

April

March

Field Safety Notice

February

January

Instruments

Biomet:

 


2016 Class I Recalls

Instrument

DuPuy Synthes Power Tool System Battery Adaptor

Greatbatch Medical Standard Offset Cup Impactor – Inadequate Sterilization

 


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

Packaging

Action

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:

  1. Review the notification and ensure that relevant personnel are aware of the contents.
  2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
  3. Your Zimmer Biomet sales representative will remove the recalled product from your facility.
  4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com.
  5. 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

Instruments

November, 2016

October, 2016

September, 2016

August, 2016

June, 2016


2015 Class I Recalls

Zimmer M/L Taper with Kinectiv Technology Prosthesis Femoral Stems and Necks Higher than Expected Levels of Manufacturing Residues

Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree


2015 Class ll Recalls

LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery

LCS COMPLETE RPS inserts various sizes. Knee prosthesis component for orthopedic surgery

Stryker Trident 10 degrees x 3 Insert 36 MM

Stryker Triathlon x3 Tibial Bearing Insert

Stryker Triathlon PS x3 Tibial Insert, No 3 Triatholon TS Plus Tibial Insert x 3 Poly 19 mm

Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component

NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3

Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile

Instruments 

Stryker MIS Modular Distal Capture Triathlon MIS Instruments

SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades

Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland