SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Reported: January 13, 2016 Initiated: December 1, 2015 #Z-0585-2016
Product Description
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
Reason for Recall
The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.
Details
- Recalling Firm
- Synthes (USA) Products LLC
- Units Affected
- 65
- Distribution
- US nationwide distibution.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.. Recalled by Synthes (USA) Products LLC. Units affected: 65.
Why was this product recalled? ▼
The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 13, 2016. Severity: Moderate. Recall number: Z-0585-2016.
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