Stryker Gamma3 End Cap Recalled Due to Compromised Sterility
Stryker GmbH is recalling specific Gamma3 End Caps because the blister pack 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. Per the rubric, this is a risk-of-harm product where injury has not yet been reported, corresponding to a score of 3.
Plain-English summary
Stryker GmbH is recalling Stryker End Cap, Std, Ti Gamma3 devices (Catalog Number 30051100S). These single-use implants are intended for the temporary fixation, correction, or stabilization of bones. 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 units are identified by Lot Number K03A7FF. The distribution was worldwide, including the United States and numerous international countries such as Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, the Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, and the United Kingdom. An update to the distribution list added Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
Healthcare providers and consumers should stop using these specific devices and contact Stryker GmbH for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - 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 (1)
- Lot Number: K03A7FF
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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