Howmedica Serrato Polyaxial Screws Recalled for Incorrect Length
Howmedica Osteonics Corp. is recalling 11 Serrato polyaxial screws because some 90mm and 100mm units were manufactured with the wrong length.
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 involves a manufacturing discrepancy (incorrect length) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Howmedica Osteonics Corp. is recalling 11 units of Serrato polyaxial screws, specifically the 9.5mm x 90mm (Catalog Number 482619590) and 9.5mm x 100mm (Catalog Number 4826195100) models. The recall affects Lot # B88751, which was distributed nationwide to California, Florida, Georgia, Massachusetts, New York, Pennsylvania, and Texas.
The recall is due to a manufacturing discrepancy where the screws were produced with incorrect lengths. Specifically, the 90mm screws in Lot B88751 were manufactured with a 100mm length, while the 100mm screws in Lot B90243 were manufactured with a 90mm length. This error means the physical dimensions of the implants do not match their labeled specifications.
Healthcare providers and facilities that have received these specific lots should stop using the affected screws and contact Howmedica Osteonics Corp. for further instructions on handling or returning the product. Patients who have already had these specific screws implanted should consult their healthcare provider to discuss the discrepancy.
The recalled product
- Product
- Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 11
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 # B88751 UDI: (01)07613327351576(11)190125(10)B88751
Distribution
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