Stryker Recalls System 6 Aseptic Housings Due to Weld Defect
Stryker is recalling 399 System 6 Aseptic Housings because a failed test revealed a lack of a continual weld. Customers are instructed to return the product to Stryker.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any hospitalizations, injuries, or deaths, and the defect is a manufacturing quality issue (failed weld test) rather than a high-risk pathogen or structural vehicle defect, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 399 units of the System 6 Aseptic Housing. This product provides a sterile enclosure for the Stryker Non-sterile Battery and serves as an accessory for powered orthopedic surgical instruments. The affected units are identified by Part No. 6126-120-000 and Lots 13205, 13209, 13210, and 13212.
The recall was initiated due to a failed Continuous Bond Line Test, which indicated that a housing lacked a continual weld. The agency has classified this recall as Class II. The affected products were distributed worldwide, including nationwide in the United States (including Puerto Rico and specific states) and in various international countries such as Australia, Canada, and France.
Customers are instructed to return the recalled product to Stryker. The source text does not report any illnesses, injuries, or deaths associated with this defect.
The recalled product
- Product
- System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Hazard
- Affected units
- 399
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 (5)
- Part No. 6126-120-000
- Lots 13205
- 13209
- 13210
- 13212
Distribution
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