DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
Reported: December 23, 2020 Initiated: November 19, 2020 #Z-0583-2021
Product Description
DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
Reason for Recall
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
Details
- Recalling Firm
- Synthes (USA) Products LLC
- Units Affected
- 651US : 326 OUS
- Distribution
- Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S. Recalled by Synthes (USA) Products LLC. Units affected: 651US : 326 OUS.
Why was this product recalled? ▼
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 23, 2020. Severity: Moderate. Recall number: Z-0583-2021.
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