Recall Z-1063-2014— Implantech Associates Inc
Class II · Terminated
Class II FDA medical device recall by Implantech Associates Inc, initiated 2014-01-29, terminated 2015-03-12. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Implantech Associates Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-29
- Terminated
- 2015-03-12
- Firm location
- Ventura, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.