SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical proc
FDA device recall Z-0585-2016 · posted 2016-01-05 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.
- Action taken
- 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
- Status
- Terminated
- Product code
- HTO
- Quantity affected
- 65
- Distribution
- US nationwide distibution.
- Date initiated
- 2015-12-01
- Date posted
- 2016-01-05
- Date terminated
- 2016-08-26
- Location
- West Chester, PA
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