Class II — Implantech Associates Inc
| Recalling firm | IMPLANTECH ASSOCIATES, INC. |
|---|---|
| Registered facility | IMPLANTECH ASSOCIATES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary. |
| Quantity | 300 |
| Distribution | Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa. |
| Initiated | 2014-01-29 |
| Classified | 2014-02-20 |
| Terminated | 2015-03-12 |
| Recall number | Z-1063-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Implantech Associates Inc (Z-1063-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67446/
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