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Terminated

SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.

FDA Recall Z-0585-2016 · Posted 2016-01-05

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeHTO
Date Initiated2015-12-01
Date Terminated2016-08-26
Product Quantity65

Reason for Recall

The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.

Firm Action

On Dec 1, 2015, Synthes issued a recall notification letter and requested that all consignees review inventory and contact Synthes for a return authorization number. The verification form is to be completed and sent to Stericycle.

Root Cause

Process design

Distribution Pattern

US nationwide distibution.

Official Source

View FDA Recall →

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

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