Gelzone Shoulder Sleeve — Class II medical device recall Z-1063-2014
Terminated recall by Implantech Associates Inc, reported 2014-02-26, distributed nationwide. Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it m
| Recall number | Z-1063-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implantech Associates Inc, Ventura, CA, United States |
| Recall initiated | 2014-01-29 |
| Classified | 2014-02-20 |
| Reported by FDA | 2014-02-26 |
| Terminated | 2015-03-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | ZA |
| Quantity | 300 |
| Lot numbers | 852766 |
| Model numbers | SLV634 |
Product
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
Reason for recall
Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure.
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-1063-2014. 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.