—#124903

Product

CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K840643, K960658
Affected lot / code info: 60275282 60089260 60145841 60147718 60156456 60089259 60156459 60200116 62135079 62079190 60732916 60638837 62094973 61887194 60457227

Why it was recalled

Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

Root cause (FDA determination)

Packaging

Action the firm took

Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.

Timeline

Recall initiated: 2013-10-11
Posted by FDA: 2014-02-20
Terminated: 2017-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124903. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.