Recall Z-1046-2016— Zimmer Biomet, Inc.

Name: FDA recall Z-1046-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-11

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2016-02-11, terminated 2016-12-01. It names one FDA 510(k) clearance: K032726. Product: M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093. Reason: 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..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-02-11
Terminated: 2016-12-01
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K032726 — ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIESZimmer, Inc.·cleared 2003-10-22

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

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

Reason for recall

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.

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