The Recall Desk
HighFDA (Devices)·Z-2385-2020·Announced 2020-06-24

Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity

Stryker GmbH is recalling specific lots of locking screws because the blister pack seal may be compromised, meaning sterility cannot be assured.

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: The recall is classified as FDA Class II. The hazard involves a potential loss of sterility in a surgical implant, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Stryker GmbH is recalling specific lots of Stryker Locking Screws, Fully Threaded T2 Tibia 5x45 mm (Catalog Number: 18965045S). These single-use medical devices are intended for the temporary fixation, correction, or stabilization of bones. The recall involves 127 units in the United States and 454 units outside the US.

The recall is being conducted because the seal integrity of the blister pack may be compromised, which means the sterility of the devices cannot be assured. The affected lot numbers are K02C1BB, K03033E, K030342, K03035D, K030F17, K030F1D, K031B6E, K031B70, and K0328A5.

The products were distributed worldwide, including in the United States and various international markets such as Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, the Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, and the United Kingdom. Additional countries including Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg were added to the distribution list in an update on July 21, 2020. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.

The recalled product

Product
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Manufacturer
Stryker GmbH
Category
Medical Device — Orthopedic Implants
Hazard

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 (9)

  • Lot Number: K02C1BB
  • K03033E
  • K030342
  • K03035D
  • K030F17
  • K030F1D
  • K031B6E
  • K031B70
  • K0328A5

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 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.

See all 15 products in this recall →

Related recalls

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Same hazard · sterility compromise

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