Stryker Compression Screw Recalled Due to Potential Sterility Compromise
Stryker GmbH is recalling specific Advanced T2 Tibia Compression Screws because the blister pack seal integrity 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 is classified as FDA Class II. The hazard involves a potential loss of sterility in a surgical implant, which presents a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker GmbH is recalling the Stryker Compression Screw, Advanced T2 Tibia (Catalog Number: 18220001S). The recall involves 26 units from Lot Number K020791. 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 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 the affected devices and contact Stryker GmbH for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
- Manufacturer
- Stryker GmbH
- Affected units
- 26
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: K020791
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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