Stryker Gamma4 Long Nail with incorrect left-nail geometry recalled
Stryker GmbH is recalling a specific lot of Gamma4 Right Long Nails (Catalog Number 84250320S) because they were manufactured with left-nail geometry instead of right-nail geometry, which could affect surgical fit and function.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical implant component with a critical geometric defect that could compromise surgical fixation integrity. Although no illnesses or injuries are reported in the source text, the defect poses a risk of harm to patients receiving the implant, and the product is surgical in nature, meeting the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker GmbH is recalling the Long Nail, RIGHT Gamma4 10x320mm x 125 (Catalog Number 84250320S, Lot Number K1BC9B7) from the Gamma4 System due to a manufacturing defect. Investigation confirmed that the right long nails were manufactured with the geometry of a left nail.
This geometric mismatch could affect proper fit and function during surgical placement, potentially compromising the integrity of the fixation system. The affected product was distributed worldwide, with US distribution in Alabama, Florida, New Jersey, and Oregon, as well as in Australia and Japan.
Healthcare providers and facilities that have received this product should discontinue use of Lot K1BC9B7 and contact Stryker GmbH for instructions on product return and replacement options. The product should not be used on patients.
The recalled product
- Product
- Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
- Manufacturer
- Stryker GmbH
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)
- Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.
Distribution
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