Synthes 13.5mm Medullary Reamer Head Recalled for Dimensional Mismatch
Synthes (USA) Products LLC is recalling 65 units of 13.5mm Medullary Reamer Heads that are actually 14mm. The devices are distributed nationwide.
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. The hazard is a dimensional labeling error (13.5mm vs 14mm) without reported injuries or illnesses, fitting the criteria for moderate severity involving potential procedural errors.
Plain-English summary
Synthes (USA) Products LLC is recalling 65 units of the SYNTHES 13.5MM Medullary Reamer Head, part number 352.135, lot number F-17180. These non-sterile devices are part of the Flexible Reamer Set used for orthopedic surgical procedures.
The recall was initiated because the devices are etched with the dimension 13.5mm, but the actual dimension is 14mm. This discrepancy could lead to the use of an incorrectly sized instrument during surgery.
The affected units were distributed nationwide in the United States. Healthcare facilities and users should stop using the affected reamer heads and contact Synthes (USA) Products LLC for further instructions.
The recalled product
- Product
- SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 65
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 (2)
- Part number: 352.135
- Lot number: F-17180
Distribution
Distributed nationwide across the United States.
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