RecallRadar

FDA Device recall Z-0222-2013

CoCr Head, sterile, Rx

On 2012-11-14 the FDA classified a Class II recall of CoCr Head, sterile, Rx by Zimmer, citing zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after recei….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0222-2013
ClassificationClass II
Statusterminated
Initiated2012-09-04
Published2012-11-14
Last updated2026-09-13 11:53 UTC
CompanyZimmer
DistributionUS

Product

CoCr Head, sterile, Rx

Reason

Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

Identifiers

code_info
REF Numbers: 01.01012.384, 01.01012.385, 01.01012.386, 01.01012.387, and 01.01012.388 Lot2369409, 2435773, 2448280, 24…REF Numbers: 01.01012.384, 01.01012.385, 01.01012.386, 01.01012.387, and 01.01012.388 Lot2369409, 2435773, 2448280, 2480485, 2480485, 2397348, , 2402739, 2412633, , 2420719, 2481695, 2520521, 2333576, 2354292, 2369416, 2398778, 2412631, 2447614, 2462604, 2484118, 2498778, 2501857, 2524940, 2524941, 2527698, 2531506, 2531507, 2330195, 2341655, 2448278, 2482086, 2512070, 2518101, 2490816, and 2498784

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0222-2013%22

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