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 medical implant, which poses a risk of harm (infection) even though specific injury reports are not detailed in the provided text.
Plain-English summary
Stryker GmbH is recalling Stryker Locking Screws, Fully Threaded T2 Tibia 5x40 mm (Catalog Number: 18965040S). The recall involves 400 units from lot numbers K0207B3, K031B6B, K031B6C, and K033439. 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. The FDA has classified this as a Class II recall.
The affected 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 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 ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Manufacturer
- Stryker GmbH
- Affected units
- 400
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: K0207B3
- K031B6B
- K031B6C
- K033439
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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