Trabecular Metal — Class II medical device recall Z-0609-2014
Terminated recall by Zimmer, Inc., reported 2014-01-08, distributed in AZ, CA, CO, FL, KS, KY, MI, NC…. Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Re
| Recall number | Z-0609-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2013-12-10 |
| Classified | 2013-12-30 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2014-09-11 |
| Distributed | AZ, CA, CO, FL, KS, KY, MI, NC, NJ, NV, OH, OK, OR, PA, SC, TN, TX, WA, WI |
| Countries outside the US | DE |
| Quantity | 25 |
| Reason classes | labeling |
| Lot numbers | 62393502 |
| Model numbers | 00-4349-036-11 |
Product
Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661
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.
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-0609-2014. 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.