Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0838-2018·Announced 2018-03-14

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.

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 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
Category: Medical Device — Surgical Instrumentation
Hazard: bioburden
infection-risk
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.

See all 4 products in this recall →

Same manufacturer · Stryker Corporation

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Same hazard · bioburden