DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Reported: June 15, 2016 Initiated: May 2, 2016 #Z-1912-2016
Product Description
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Reason for Recall
Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.
Details
- Recalling Firm
- Synthes (USA) Products LLC
- Units Affected
- 244 units
- Distribution
- US nationwide distribution.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43. Recalled by Synthes (USA) Products LLC. Units affected: 244 units.
Why was this product recalled? ▼
Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 15, 2016. Severity: Moderate. Recall number: Z-1912-2016.
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