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Terminated

IMHS CP, 3.2mm, Tip Threaded Guide Pin, REF71687000, for use with IntraMedullary Hip Screw in orthopedic surgery.

FDA Recall Z-1704-2009 · Posted 2009-08-04

Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeLXH
Date Initiated2009-01-22
Date Terminated2011-08-18
Product Quantity99 units

Reason for Recall

Incorrect depth gauge mark etched onto guide wire pin. Guide pin is too long.

Firm Action

Urgent Medical Device Recall letter dated January 23, 2009. All affected Smith & Nephew Sales Representatives, Distributors and Hospitals were notified of problem and the recall via Fed Ex and e-mail on 01/22/2009. They were instructed to immediately check their inventory and return the product.

Root Cause

Process design

Distribution Pattern

Distribution to USA, Switzerland and Australia.

Official Source

View FDA Recall →

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

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