The Recall Desk
HighFDA (Devices)·Z-2380-2020·Announced 2020-06-24

Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity

Stryker GmbH is recalling specific 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 involves a risk-of-harm product (sterile medical device) where sterility cannot be assured, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.

Plain-English summary

Stryker GmbH is recalling Stryker Locking Screws, Fully Threaded T2 Humerus 4x32 mm (Catalog Number: 18964032S). The recall involves 40 units from Lot Number K0207C2. These single-use devices are intended for the temporary fixation, correction, or stabilization of bones.

The recall is being issued because the seal integrity of the blister pack may be compromised. As a result, the sterility of the devices cannot be assured. The products were distributed worldwide, including in the United States, Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, 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 and facilities that have received these products should stop using them and contact Stryker for further instructions. Patients who have already had these implants placed should consult their healthcare provider if they have concerns regarding the sterility of the device.

The recalled product

Product
Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - 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
40

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: K0207C2

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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