Z-0828-2011

CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX

Name: Z-0828-2011 CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX
Creator: Encore Medical, Lp
Published: 2010-11-10
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2010-11-10 / Terminated

FDA source

Encore Medical, Lp began a recall of CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX on 2010-11-10. The reason FDA records is "Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0828-2011
Status: Terminated
Initiated: 2010-11-10
Posted: 2010-12-28
Terminated: 2011-04-25
Recalling firm: Encore Medical, LP
Product: CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.
Product code: HWB Extractor
Reason for recall: Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay.
FDA 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 in commerce: 27 Units
Distribution: Nationwide Distribution to the states of AZ, CA, FL, GA, ID, KS, MO, NY, TX, and WI.
Product codes and lots: Device Listing Number: A776463. Device Part Number: 803-08-033. Lot/Serial Numbers: 34596L02, 32503L02, 32503L01(B)

Product code HWB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)