Tennis Elbow Support — Class II medical device recall Z-1606-2014
Terminated recall by Zimmer, Inc., reported 2014-05-21, distributed nationwide. During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as l
| Recall number | Z-1606-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-03-19 |
| Classified | 2014-05-09 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2015-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, IQ, IT, SA, TN |
| Quantity | 649 units |
| Reason classes | labeling |
| Model numbers | 00-3448-003-00 |
Product
Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.
Reason for recall
During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
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-1606-2014. 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.