Stryker Nail Insertion Sleeve Recalled for Inner Diameter Mismatch
Stryker GmbH is recalling 242 Nail Insertion Sleeves (Catalog Number 18061406S, Lot K03CC4F) because the inner diameter does not match the dimension specified on the outer box label.
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: FDA Class II recall of a surgical device where the actual product dimensions do not match labeled specifications. The rubric categorizes risk-of-harm products where injury has not yet been reported as High severity.
Plain-English summary
Stryker GmbH is recalling Nail Insertion Sleeve, elastic T2 Tibia SPI ø8-11 (Catalog Number 18061406S). A total of 242 units with Lot Number K03CC4F were distributed nationwide in the United States.
The recalled devices have an inner diameter that does not match the diameter specified on the outer box label. The dimensional discrepancy was identified and reported to the FDA, resulting in the recall issuance.
No injuries or illnesses have been reported in connection with these devices.
The recalled product
- Product
- Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
- Manufacturer
- Stryker GmbH
- Affected units
- 242
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)
- GTIN 04546540715357
- Lot Number K03CC4F
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Stryker GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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