Stryker Locking Screw Recall Due to Potential Sterility Compromise
Stryker is recalling specific locking screws because the packaging seal may be compromised, meaning sterility cannot be assured.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device where sterility cannot be assured, posing a risk of infection or harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Stryker GmbH is recalling Stryker Locking Screws, Partially Threaded T2 Tibia 5x55 mm (Catalog Number: 18915055S). The recall is being conducted because the seal integrity of the blister pack may be compromised, which means the sterility of the device cannot be assured.
The affected units are identified by Lot Number K01CF9F. The recall involves 3 units in the United States and 13 units outside the United States. The products were distributed worldwide, including in 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 implants are single-use devices intended for the temporary fixation, correction, or stabilization of bones. Because the sterility of the devices cannot be guaranteed, healthcare providers should stop using the affected units and contact Stryker for further instructions.
The recalled product
- Product
- Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - 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 (1)
- Lot Number: K01CF9F
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
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