The Recall Desk
HighFDA (Devices)·Z-2171-2021·Announced 2021-08-11

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.

What this means for you

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
Category
Medical Device — Orthopedic Surgery
Hazard
  • dimensional-defect
  • specification-mismatch

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.

Related recalls

Same category