FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.
- Recall number
- Z-0828-2011
- Recalling firm
- Encore Medical, Lp
- Product
- CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX.
- Status
- Terminated
- Initiated
- 2010-11-10
- Posted
- 2010-12-28
- Terminated
- 2011-04-25
- 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.
- Lot, serial or model codes
- Device Listing Number: A776463. Device Part Number: 803-08-033. Lot/Serial Numbers: 34596L02, 32503L02, 32503L01(B)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWB
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28