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Terminated

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

FDA Recall Z-0828-2011 · Posted 2010-12-28

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeHWB
Date Initiated2010-11-10
Date Terminated2011-04-25
Product Quantity27 Units

Reason for Recall

Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution to the states of AZ, CA, FL, GA, ID, KS, MO, NY, TX, and WI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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