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Terminated

Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by defi ciencies of the femoral head, neck, or portions of the proximal femur. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability.

FDA Recall Z-0610-2014 · Posted 2013-12-30

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeJDI
Date Initiated2013-12-10
Date Terminated2014-09-11
Product Quantity3

Reason for Recall

Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.

Firm Action

Zimmer sent an Urgent Medical Device Recall letter dated December 10, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel were aware of the contents. If affected product was found, it should be quarantines and their Zimmer representative notified. The Zimmer sales representative will remove the recalled product from their facility. Customers with questions were instructed to call 1-877-946-2761. .

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution -USA including OH, FL, WI, MI NJ, SC, CA, NC, PA, OR, WA, TN, KY, OK, KS, AZ, TX, CO, NV and Internationally to Germany. There have been 71 distribution events. Note that this product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf. 7 units have been returned, including three through the complaint process, which leaves 64 affected units in the field subject to removal.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960658COLLARLESS POLISHED TAPER HIP PROSTHESISZimmer, Inc. · 1996-07-16K913649MODULAR CALCAR REPLACEMENTZimmer, Inc. · 1991-11-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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