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Terminated

Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G

FDA Recall Z-0328-06 · Posted 2005-12-28

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeLXH
Date Initiated2005-10-21
Date Terminated2008-04-16
Product Quantity141 units.

Reason for Recall

Detachable T-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled.

Firm Action

The firm initiated the recall on 10/21/05 via letter to all consignees.

Root Cause

Other

Distribution Pattern

Device distributed nationwide to direct accounts in AZ, CA, FL, GA, IA, IL, KS, LA, MA, MD, MI, MO, MT, NM, NH, NJ, OK, OH, PA, SC, SD, TX, UT, VA, and WA. Foreign distribution to Saudi Arabia, Japan and Germany.

Official Source

View FDA Recall →

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

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