Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
This recall has been terminated (originally issued April 2, 2018).
- Company
- Zimmer Biomet, Inc.
- Recall Initiated
- April 2, 2018
- Terminated
- May 12, 2020
- Recall Number
- Z-1538-2018
- Quantity
- 18
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
Distribution
Worldwide Distribution: US (nationwide) in states of: AL, AR, FL, GA, IN, KY, LA, MO, MS, OH, OK, TX, and VA; and countries of: Canada, Costa Rica and Chile.
Lot / Code Info
lot 299340
Root Cause
Nonconforming Material/Component
Action Taken
The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 4/2/2018 to its customers. The letter described the product, problem and actions to be taken. Distributors will be notified of the recall via email. Hospital risk managers and distributors with product will be notified via courier. The distributor letter includes instructions to locate and remove the product in their territory, identify hospitals who have previously used the product; return on-hand product to the recalling firm and ensure all products are accounted for. The letter for hospital risk managers instruct the risk managers to assist the recalling firm's sales reps with quarantine of the product; to review notification and ensure affected personnel are aware of the contents; and complete and return the Certificate of Acknowledgement form to CorporateQuality.PostMarket@zimmerbiomet.com, even if you do not have product, and retain a copy. Customers with questions are directed to call customer service at 574-371-3071 between 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.