FDA Device recall Z-1063-2014
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766
- FDA Device
- Class II
- terminated
- Published 2014-02-26
On 2014-02-26 the FDA classified a Class II recall of Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766 by Implantech Associates, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1063-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-29 |
| Published | 2014-02-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Implantech Associates |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog Number SLV634, Lot Number 852766. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1063-2014%22
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