Synthes Recalls Cervical Spine Screws Due to Lot Swapping Error
Synthes (USA) Products LLC is voluntarily recalling specific lots of cervical spine screws because two different screw types were swapped during manufacturing.
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 text describes a logistical error (lot swapping) without reporting any patient injuries, illnesses, or deaths. Per the rubric, this aligns with a voluntary precautionary recall or minor error where no harm has been reported.
Plain-English summary
Synthes (USA) Products LLC is initiating a voluntary recall of specific lots of 4mm screws used in the Cervical Spine Locking Plate (CSLP) System. The recall involves Lot # 9666776 (4mm Cancellous Self Tapping Screw, Length 16mm) and Lot # 9671879 (4mm Cortex Standard Screw, Length 16mm). The total quantity affected is 30 units of Lot # 9666776 and 11 units of Lot # 9671879.
The recall was initiated because a single lot of 450.136 screws was discovered to have been swapped with a single lot of 450.016 screws. This error resulted in the wrong type of screw being associated with the specific lot numbers.
The affected products were distributed worldwide, including nationwide in the United States (specifically in NC, CA, NY, TX, NJ, and CO) and in the countries of Ontario and Canada. Healthcare providers and facilities that have received these specific lots should stop using them and contact Synthes for instructions on return or replacement.
The recalled product
- Product
- Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879
- Manufacturer
- Synthes (USA) Products LLC
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 (1)
- Lot # 9666776 (catalog ID 450.136) and 9671879 (catalog ID 450.016)
Distribution
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