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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes

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  Class 2 Device Recall Synthes see related information
Date Initiated by Firm December 01, 2015
Date Posted January 05, 2016
Recall Status1 Terminated 3 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 2		 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.
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