Stryker Locking Screw Recall Due to Compromised Blister Pack Seal Integrity
Stryker 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 risk of infection due to compromised sterility, which is a high-risk scenario for a medical implant, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker GmbH is recalling specific lots of Locking Screw, Fully Threaded T2 Tibia 5x37.5 mm (Catalog Number: 18965037S). The recall is due to a potential defect where the seal integrity of the blister pack may be compromised, meaning the sterility of the device cannot be assured.
The affected lots are K029C38, K029C39, K030EF6, K030EF7, K030EF9, and K031B66. The recall covers 76 units in the United States and 290 units outside the United States. Distribution was worldwide, including the US, 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.
These single-use devices are intended for the temporary fixation, correction, or stabilization of bones. 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 T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Manufacturer
- Stryker GmbH
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 (6)
- Lot Number: K029C38
- K029C39
- K030EF6
- K030EF7
- K030EF9
- K031B66
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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