Synthes Universal Spinal System Lamina Hooks Recalled for Incorrect Etching
Synthes (USA) Products LLC is recalling 12 units of Universal Spinal System Lamina Hooks because they are etched with the wrong part number.
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 hazard is a minor labeling/etching error (wrong part number) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Synthes (USA) Products LLC is recalling 12 units of Universal Spinal System Lamina Hooks, specifically the Synthes Medium TI Lamina Hook - Right (Catalog number 498.321, lot/serial #6876785). These non-sterile devices are intended for noncervical spinal fixation in skeletally mature patients.
The recall was initiated because the hooks are etched with the wrong part number. The devices are currently marked with part number 498.321, which corresponds to the Lamina Hook, Medium, Left. They should be etched with part number 498.320, which corresponds to the Lamina Hook, Medium, Right.
The affected units were distributed nationwide, including in Georgia, Pennsylvania, South Carolina, Texas, and Utah, as well as in Canada. Healthcare providers and facilities should check their inventory for these specific units and stop using them if found.
The recalled product
- Product
- Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature…
- Manufacturer
- Synthes (USA) Products LLC
- Category
- Medical Device — Spinal Fixation
- Hazard
- Affected units
- 12
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)
- Catalog number 498.321
- lot/serial #6876785
Distribution
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