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Terminated

Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.

FDA Recall Z-0408-2014 · Posted 2013-11-27

Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeHTW
Date Initiated2013-07-31
Date Terminated2015-06-01
Product Quantity166

Reason for Recall

There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.

Firm Action

Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450.

Root Cause

Device Design

Distribution Pattern

USA Nationwide Distribution

Official Source

View FDA Recall →

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

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