Recall Z-0828-2011
Encore Medical, Lp · initiated November 10, 2010
Product
CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.
Codes / lots: Device Listing Number: A776463. Device Part Number: 803-08-033. Lot/Serial Numbers: 34596L02, 32503L02, 32503L01(B)
Reason for recall
Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay.
FDA-determined cause: Other
Action taken
DJO issued an Urgent Recall Notice letter dated November 10, 2010 to consignees identifying the affected devices and requesting return of all affected devices for replacement. Customers are also requested to complete and return an enclosed Recall Response Form. Customers can contact David Harris of DJO at 512 834-6330 with questions about this recall.
Details
- Recall number
- Z-0828-2011
- Initiated
- November 10, 2010
- Posted by FDA
- December 28, 2010
- Terminated
- April 25, 2011
- Product code
- HWB – Extractor
- Quantity
- 27 Units
- Distribution
- Nationwide Distribution to the states of AZ, CA, FL, GA, ID, KS, MO, NY, TX, and WI.
- Recalling firm
- Encore Medical, Lp, Austin, TX