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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
Related recalls
Same manufacturer · Synthes (USA) Products LLC
See all →- HighVOLT locking screw taps swapped between lots carry incorrect thread
FDA (Devices) · 2026-04-08
- HighVOLT bone taps swapped between lots carry the incorrect thread
FDA (Devices) · 2026-04-08
- ModerateLocking bone screws recalled after packaging labeled with the wrong length
FDA (Devices) · 2025-10-29
- ModerateForty six millimetre locking screws recalled over wrong length on packaging
FDA (Devices) · 2025-10-29
- HighSurgical screwdrivers recalled for failure to engage with implant screws
FDA (Devices) · 2024-06-05
Same hazard · cytotoxicity
See all →- ModerateMulti-Snare Set catheter fails biocompatibility requirements
FDA (Devices) · 2026-07-01
- HighBayonet injection needles recalled after showing elevated cytotoxicity in testing
FDA (Devices) · 2025-08-27
- HighYukon Straight Rod spinal implants recalled for discoloration and contamination
FDA (Devices) · 2022-07-06
- SevereEBI Patient Care Recalls SpF-PLUS Implantable Stimulators Due to Cytotoxicity
FDA (Devices) · 2017-05-31
- SevereEBI Patient Care Recalls Spinal Fusion Stimulators Due to Cytotoxicity
FDA (Devices) · 2017-05-31
Similar recalls
- SevereDePuy Synthes 14.5mm Reamer Head Recalled for Breakage and Tissue Damage
FDA (Devices) · 2020-12-23
- SevereDePuy Synthes 18.0mm Reamer Head Recalled for Breakage and Tissue Damage
FDA (Devices) · 2020-12-23
- SevereDePuy Synthes 11.5mm Reamer Head Recalled for Breakage Risk
FDA (Devices) · 2020-12-23
- SevereDePuy Synthes 10.5mm Reamer Head Recalled for Breakage and Tissue Damage
FDA (Devices) · 2020-12-23
- SevereDePuy Synthes 13.5mm Reamer Head Recalled for Breakage and Tissue Damage
FDA (Devices) · 2020-12-23
- SevereDePuy Synthes 12.5mm Reamer Head Recalled for Breakage and Tissue Damage
FDA (Devices) · 2020-12-23