Stryker Locking Screw Recall Due to Potential Sterility Compromise
Stryker GmbH is recalling specific lots of locking screws because blister pack seals may be compromised, potentially affecting sterility.
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 implant) where the hazard is a potential loss of sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Stryker GmbH is recalling specific lots of Stryker Locking Screws, Fully Threaded T2 Tibia 5x30 mm (Catalog Number 18965030S). The recall involves 46 units in the United States and 314 units outside the United States. The affected lot numbers are K0207B0, K02C1A8, K02C1A9, and K0302E4.
The recall was initiated because the seal integrity of the blister pack may be compromised, meaning the sterility of the devices cannot be assured. These single-use implants are intended for the temporary fixation, correction, or stabilization of bones.
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, United Kingdom, Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg. Healthcare providers should stop using these specific lots and contact Stryker for instructions on return or replacement.
The recalled product
- Product
- Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Manufacturer
- Stryker GmbH
- 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 (4)
- Lot Number: K0207B0
- K02C1A8
- K02C1A9
- K0302E4
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.
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