The Recall Desk
HighFDA (Devices)·Z-2373-2020·Announced 2020-06-24

Stryker Locking Screw Recall Due to Compromised Sterility

Stryker is recalling specific locking screws because the packaging 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 medical implant, which poses a risk of harm (infection) even though specific injury reports are not detailed in the source text.

Plain-English summary

Stryker GmbH is recalling Stryker Locking Screws, Fully Threaded S2 05x35 mm (Catalog Number: 17965035S). The recall involves 56 units from Lot Number K0386FB. These single-use medical devices are intended for the temporary fixation, correction, or stabilization of bones.

The recall was initiated because the seal integrity of the blister pack may be compromised. As a result, the sterility of the devices cannot be assured. This is classified as an FDA Class II recall.

The affected products were distributed worldwide, including in the United States, Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, the Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, and the United Kingdom. An update on July 21, 2020, added Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg to the distribution list. Healthcare providers should stop using the affected lots and contact Stryker for instructions on return or replacement.

The recalled product

Product
Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - 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
Affected units
56

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 (1)

  • Lot Number: K0386FB

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

Same manufacturer · Stryker GmbH

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Same hazard · sterility compromise

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