—#191906

Product

Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614

FDA product code: MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lot Number: 439470 UDI: (01)00880304554153(17) 290803(10)439470

Why it was recalled

The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.

Root cause (FDA determination)

Process control

Action the firm took

Zimmer Biomet issued Urgent Medical Device Recall Letter (ZFA 2021-00267) to Distributors, Risk Managers, and Surgeons on January 7, 2022 via FedEx. For US and OUS distributors, the notification was completed via email . Letter states reason for recall, health risk and action to take: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. If the product has been implanted, Zimmer Biomet recommends assessing the patient with imaging and monitoring the patient for third body debris or loosening that could potentially contribute to the potential health risks. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 4. Retain a copy of the

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.

Timeline

Recall initiated: 2022-01-07
Terminated: 2023-04-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191906. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.