Recall Z-0610-2014— Zimmer, Inc.

Name: FDA recall Z-0610-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-10

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-12-10, terminated 2014-09-11. It names 2 FDA 510(k) clearances: K960658, K913649. Product: 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.. Reason: 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..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-10
Terminated: 2014-09-11
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K960658 — COLLARLESS POLISHED TAPER HIP PROSTHESISZimmer, Inc.·cleared 1996-07-16
K913649 — MODULAR CALCAR REPLACEMENTZimmer, Inc.·cleared 1991-11-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.