Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1063-2014 — Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.

U.S. FDA — Device Enforcement · United States · 2014-01-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1063-2014
Date of alert: 2014-01-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Implantech Associates Inc
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1063-2014 — Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.

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