Stryker Recalls ACL Disposable Packs Due to Bioburden Levels
Stryker is recalling ACL Disposable Pack Bone-Tendon-Bone units because routine testing found bioburden levels higher than internal acceptable rates.
What this means for you
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 hazard involves bioburden levels exceeding internal rates without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Corporation is recalling ACL Disposable Pack Bone-Tendon-Bone, Model 0234020280, which are labeled sterile. The product is a single-surgery use, disposable set of instrumentation intended for anterior cruciate ligament (ACL) reconstruction surgeries.
The recall was initiated after routine bioburden testing of certain lots revealed levels higher than internal acceptable rates. The specific lot number is 17299AG2, and the UDI is 07613154643264. A total of 60,753 units are involved in this recall.
The affected units were distributed domestically and internationally to Australia and Mexico. Healthcare facilities and providers should stop using the affected units and contact Stryker Corporation for further instructions.
The recalled product
- Product
- ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
- Manufacturer
- Stryker Corporation
- Hazard
- Affected units
- 60,753
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 (3)
- Model 0234020280
- UDI 07613154643264
- Lot No. 17299AG2
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Stryker Corporation 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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