Stryker Trident Constrained Liner Inserter Impactor Tip Recall
Stryker is recalling Trident Constrained Liner Inserter Impactor Tips because they do not meet required sterility assurance levels when steam sterilized.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the failure to meet sterility assurance levels for a surgical implant.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tips in 22 mm, 28 mm, and 32 mm sizes. The affected catalog numbers are 2199-2022, 2199-2028, and 2199-2032. These non-sterile devices are intended for use in total hip arthroplasty.
The recall was initiated because the impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method. A total of 1,864 units were distributed worldwide, including in the United States, Sweden, South Africa, Chile, Australia, New Zealand, Canada, the United Kingdom, Switzerland, Colombia, and Poland.
Healthcare facilities and consumers should stop using these devices immediately. Stryker Howmedica Osteonics Corp. is the recalling firm responsible for managing the recall.
The recalled product
- Product
- Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 1,864
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)
- Catalog Nos. 2199-2022
- 2199-2028 and 2199-2032 All lots manufactured from May 30
- 2012
Distribution
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