Data Foundry

Medical device recalls 2012

Coonrad/Morrey New Ulnar Revision Kit for Use with… — Class II medical device recall Z-0538-2013

Terminated recall by Zimmer, Inc., reported 2012-12-26, distributed nationwide. Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instea

Recall numberZ-0538-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmZimmer, Inc., Warsaw, IN, United States
Recall initiated2012-11-19
Classified2012-12-17
Reported by FDA2012-12-26
Terminated2014-04-17
DistributedNationwide (US)
Countries outside the USCA, CH, DE, FI, GB, IT, JP
Quantity17
Lot numbers61722176
Model numbers32-8105-029-00-29

Product

Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.

Reason for recall

Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0538-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.