The Recall Desk
HighFDA (Devices)·Z-2170-2021·Announced 2021-08-11

Stryker Nail Insertion Sleeve Recalled for Incorrect Inner Diameter

Stryker is recalling Nail Insertion Sleeves with incorrect inner diameters that do not match the box label. The dimensional mismatch could affect proper fit during orthopedic surgical procedures.

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: This is an FDA Class II medical device recall involving a structural defect—incorrect inner diameter that does not match the labeled specification. As a surgical orthopedic device where dimensional accuracy is critical to proper fit and function, it qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Stryker GmbH is recalling the Nail Insertion Sleeve, elastic T2 Tibia SPI ø8-13 (Catalog Number 18061407S, Lot K03CC50). The affected devices have an inner diameter that does not match the diameter specified on the outer box label.

The dimensional mismatch could potentially affect the proper fit and function of the device during orthopedic surgical procedures. No illnesses or injuries related to this issue have been reported at this time.

The recalled devices were distributed nationwide throughout the United States, with 52 units affected. If you have received or used this product, contact your healthcare provider or Stryker GmbH immediately. Do not use the affected devices.

The recalled product

Product
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
Manufacturer
Stryker GmbH
Category
Medical Device — Orthopedic Surgical Device
Hazard
  • dimension-mismatch
  • device-defect

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 07613327005417
  • Lot Number K03CC50

Distribution

Distributed nationwide across the United States.

Related recalls

Same category