—#143788

Product

M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K032726
Affected lot / code info: Item: 00-7711-012-20, Lot: 62937093

Why it was recalled

Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Zimmer, Inc. initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. Electronic notices were e-mailed to distributors, and letters were mailed via certified mail on 02/11/2016 to distributors and hospitals. A field complaint investigation confirmed that this single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended Offset, and the device is an extended offset stem. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: Assisting the Zimmer Biomet sales representative with the quarantine of the product and completion and return of the Acknowledgement Form. Customers are asked to complete the Certificate of Acknowledgement Form and return to corporatequality.postmarket@zimmerbiomet.com. Customers with have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.

Timeline

Recall initiated: 2016-02-11
Terminated: 2016-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143788. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.