Stryker T2 Orthopedic Nails Recalled for Incomplete Sterility Seal
Stryker GmbH is recalling 38 T2 orthopedic nails due to incomplete Tyvek lid seals that may compromise sterility.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Stryker GmbH is recalling 38 units of T2 orthopedic nails, including ankle arthrodesis and proximal humeral models, due to a manufacturing defect. The recall involves specific item numbers and lot numbers distributed to Kentucky.
The defect involves an incomplete seal on the Tyvek lid, which may compromise the sterility of the device. This could potentially expose patients to infection if the devices are used.
Healthcare providers and facilities that have received these specific lots should stop using the affected devices and contact Stryker for instructions on return or replacement. Patients who have already had these devices implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm…
- Manufacturer
- Stryker GmbH
- Affected units
- 38
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 (6)
- Item Number Lot Number: 1819-1020S K0ACFED
- 1819-1220S K0CAEC4
- 1832-2824S K0BF6C6
- 1832-2828S K0CC742
- 1832-3826S K0BF6D2
- 1818-1115S K0B906C
Distribution
Distributed in 1 state:
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