Class 2 Device Recall Synthes

• Date Initiated by Firm: December 01, 2015
• Date Posted: January 05, 2016
• Recall Status: Terminated on August 26, 2016
• Recall Number: Z-0585-2016
• Recall Event ID: 72774
• Product Classification: Reamer. Manual surgical orthopedic instrument - Product Code HTO
• Product: SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
• Code Information: Part number: 352.135; Lot number: F-17180
• Recalling Firm/ Manufacturer: Synthes (USA) Products LLC; 1301 Goshen Pkwy; West Chester PA 19380-5986
• For Additional Information Contact: 610-719-6500
• Manufacturer Reason for Recall: The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.
• FDA Determined Cause: Process design
• 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.
• Quantity in Commerce: 65
• Distribution: US nationwide distibution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.