Synthes Recalls Spinal Pedicle Fixation Rods Due to Finishing Process Error
Synthes (USA) Products LLC is recalling 492 spinal pedicle fixation rods because they were produced using a bead blast process not identified in the manufacturing specification.
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 the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthes (USA) Products LLC is recalling 492 units of 5.0mm Unit Rods (270mm to 450mm) used for spinal pedicle fixation. These orthoses are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The affected products were distributed nationwide.
The recall was initiated because the products were produced using a finishing process not identified as part of the manufacturing specification. Specifically, the lots subject to this recall used a bead blast process instead of the specified shot peened process.
Healthcare providers and patients should check their inventory and patient records for the specific part numbers and lot numbers listed in the recall notice to identify affected units. Synthes (USA) Products LLC is the recalling firm responsible for managing the recall.
The recalled product
- Product
- 5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 492
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)
- 4841209
- 4923651
- 4923652
- 4987688
- 4987750
- 5350635
- 2002330
- 3000595
- 4729952
- 4841210
- 4923653
- 4923654
- 4987683
- 4856248
- 4987755
- 5153848
- 5153853
- 1602596
- 1880489
- 4729953
Distribution
Distributed nationwide across the United States.
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