CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.
FDA device recall Z-0828-2011 · posted 2010-12-28 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HWB
- Quantity affected
- 27 Units
- Distribution
- Nationwide Distribution to the states of AZ, CA, FL, GA, ID, KS, MO, NY, TX, and WI.
- Date initiated
- 2010-11-10
- Date posted
- 2010-12-28
- Date terminated
- 2011-04-25
- Location
- Austin, TX
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