DePuy Synthes Flexible Shaft Reamers Recalled for Cytotoxicity Failure
Synthes (USA) Products LLC is recalling 244 DePuy Synthes 8.0 mm Flexible Shaft Reamers because they failed biological safety evaluations for cytotoxicity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (cytotoxicity) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Synthes (USA) Products LLC is recalling 244 units of the DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument (Part number 351.43). The devices were distributed nationwide in the United States.
The recall was initiated because the devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. High growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This condition could potentially be reproduced during use and reprocessing.
Healthcare providers and facilities that have received these specific lot numbers should stop using the devices and contact the recalling firm for instructions on return or replacement. The affected lot numbers include XXX5071, 3945479, 4738380, XXX5072, 3997000, 4816738, XXX5073, 3996999, 4816739, A3CN449, 3997338, 4441056, 3007721, 4326050, 5407442, 3148892, 4307973, 5582819, 3175916, 4387338, 5722664, 3175202, 4441055, 5813837, 3175201, 4441079, 5786778, 3921562, 4559672, 5800844, 3928332, 4561383, 5903413, 3935789, 4619549, and 5910995.
The recalled product
- Product
- DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 244
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog ID # 351.43 Lot numbers: XXX5071
- 3945479
- 4738380
- XXX5072
- 3997000
- 4816738
- XXX5073
- 3996999
- 4816739
- A3CN449
- 3997338
- 4441056
- 3007721
- 4326050
- 5407442
- 3148892
- 4307973
- 5582819
- 3175916
- 4387338
Distribution
Distributed nationwide across the United States.
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