CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.
This recall has been terminated (originally issued December 28, 2010).
- Recall Initiated
- November 10, 2010
- Posted
- December 28, 2010
- Terminated
- April 25, 2011
- Recall Number
- Z-0828-2011
- Quantity
- 27 Units
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay.
Distribution
Nationwide Distribution to the states of AZ, CA, FL, GA, ID, KS, MO, NY, TX, and WI.
Lot / Code Info
Device Listing Number: A776463. Device Part Number: 803-08-033. Lot/Serial Numbers: 34596L02, 32503L02, 32503L01(B)
Root 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.