Recall Z-0828-2011 ยท HWB Extractor
Encore Medical, Lp
CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.
| Date | Dec 28, 2010 (initiated Nov 10, 2010) |
| Status | Terminated |
| Reason | Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay. |
| Root cause | Other |
| Action | 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. |
| Quantity | 27 Units |
| Distribution | Nationwide Distribution to the states of AZ, CA, FL, GA, ID, KS, MO, NY, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.