Recall Z-1063-2014
Implantech Associates Inc · initiated January 29, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
Codes / lots: Catalog Number SLV634, Lot Number 852766.
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
Implantech sent a Recall Notification letters dated January 29, 2014 via mail and fax to the affected customers. The recall notification letter informed customers of the voluntary recall, product description with code information, reason for recall, contact information, and actions to be taken. The letter also contains a response section to be completed and returned via fax. For questions call 1-800-733-0833 x235.
Details
- Recall number
- Z-1063-2014
- Initiated
- January 29, 2014
- Posted by FDA
- February 20, 2014
- Terminated
- March 12, 2015
- Product code
- HST – Apparatus, Traction, Non-Powered
- Quantity
- 300
- Distribution
- Worldwide Distribution - USA (nationwide) in the states of: CA, AZ, IL, NC, CO and the country of: South Africa.
- Recalling firm
- Implantech Associates Inc, Ventura, CA