Recalls / —
—#113257
Product
zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, Glenoid M, cemented, sterile; REF 01.04214.370, Glenoid L, cemented, sterile; REF 01.04214.400 PE Keeled Glenoid L, cemented, sterile; REF 01.04214.405
- FDA product code
- KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K051623, K990136
- Affected lot / code info
- REF Numbers: 01.04214.340, 01.04214.345, 01.04214.370, 01.04214.400, and 01.04214.405. Lot 2416527, 2430357, 2447460, 2450204, 2348311, 2348311, 2364768, 2364768, 2364768, 2403597, 2418592, 2418592, 2452946, 2453947, 2503319, 2503319, 2517200, 2329832, 2349655, 2388161, 2453280, 2453280, and 2533474.
Why it was recalled
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Root cause (FDA determination)
Error in labeling
Action the firm took
Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.
Recalling firm
- Firm
- Zimmer, Inc.
- Address
- 345 E Main St, Warsaw, Indiana 46580-2746
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2012-09-04
- Posted by FDA
- 2012-11-06
- Terminated
- 2014-04-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #113257. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.