Synthes Recalls 5.0mm Stainless Steel Spinal Rods Due to Process Error
Synthes USA is recalling 492 units of 5.0mm stainless steel spinal rods because they were produced using a finishing 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, but the source explicitly states that no adverse events were received and a safety review concluded there is no incremental risk, fitting the criteria for a voluntary precautionary recall or low-risk contamination.
Plain-English summary
Synthes USA HQ, Inc. has issued a Medical Device Correction notice for 492 units of 5.0mm stainless steel rods used in the pedicle screw spinal system. The affected products are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The recall covers specific part numbers ranging from 298.269 to 298.278, distributed nationwide.
The recall was initiated because the product was produced using a finishing process that was not identified as part of the manufacturing specification. According to the source text, no adverse event reports associated with the use of this product were received. An extensive engineering and medical safety review concluded that the product poses no incremental risk to patients.
This recall is classified as FDA Class II. Healthcare providers and patients should verify their inventory or implanted devices against the specific part numbers and lot numbers listed in the official recall notice to determine if they are affected.
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 pedicle screw spinal system; Intended to provide…
- Manufacturer
- Synthes USA HQ, Inc.
- 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
- 4841211
- 4923666
Distribution
Distributed nationwide across the United States.
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