Synthes B37 Replacement Screws Recalled for Potential Mislabeling
Synthes, Inc. is recalling 44 B37 Replacement Screws because the package may not contain the screws identified on the label.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mislabeling) without reported injuries or illnesses, which aligns with the rubric for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
Synthes, Inc. is recalling 44 units of Synthes B37 Replacement Screws. These are M3.5 screws for the insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026, used with the Low Bend Medial Distal Tibia Plate. The recall covers all lots of part no. B37, specifically lot numbers 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937.
The recall was initiated due to potential mislabeling, where the package may not contain the screws identified on the label. The products were distributed in the United States, including the District of Columbia and the states of Kentucky, Pennsylvania, Illinois, Washington, Arizona, California, Oklahoma, Florida, and Kansas.
Healthcare providers and facilities should check their inventory for these specific part numbers and lot numbers. If the recalled screws are found, they should be removed from use and returned to Synthes, Inc. according to the company's instructions.
The recalled product
- Product
- Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 44
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 (6)
- All lots of part no. B37: 6350586
- 6771518
- 7086318
- 7386422
- 7523960
- and 7548937.
Distribution
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