Stryker Recalls T2 Knee Arthrodesis Nails Due to Sterile Barrier Breach Risk
Stryker is recalling 532 units of T2 Knee Arthrodesis Nails because of a potential breach in the sterile packaging barrier.
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 is classified as FDA Class II, and the hazard involves a potential breach of the sterile barrier for an implanted medical device, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 532 units of the T2 Arthrodesis Nailing System. The recall involves specific lots of T2 Knee Arthrodesis Nails that were distributed nationwide in the United States.
The recall was initiated because Stryker became aware of a potential for breach of the sterile barrier of the packaging associated with these specific lots. The T2 Arthrodesis Nail is a medical device intended for the treatment of knee arthrodesis, including cases of aseptic failed total knee arthroplasty and various fractures.
Healthcare providers and patients should check their inventory or medical records for the specific catalogue numbers and lot numbers listed in the official recall notice. If a patient has received one of the affected devices, they should contact their healthcare provider for further instructions.
The recalled product
- Product
- Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 532
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 (20)
- Code information is listed as Catalogue Number
- LEFT ¿11.5 x 540mm K948548 18291104S Arthrodesis Nail
- LEFT ¿11.5 x 540mm K102535 18291104S Arthrodesis Nail
- LEFT ¿11.5 x 540mm K141824 18291104S Arthrodesis Nail
- LEFT ¿11.5 x 540mm K155506 18291104S Arthrodesis Nail
- LEFT ¿11.5 x 540mm K114992 18291104S Arthrodesis Nail
- LEFT ¿11.5 x 540mm K395488 18291104S Arthrodesis Nail
- LEFT ¿11.5 x 540mm K105496 18291104S Arthrodesis Nail
- LEFT ¿11.5 x 540mm K923725 18291104S Arthrodesis Nail
- LEFT ¿11.5 x 540mm K252636 18291108S Arthrodesis Nail
- LEFT ¿11.5 x 580mm K137348 18291108S Arthrodesis Nail
- LEFT ¿11.5 x 580mm K965902 18291108S Arthrodesis Nail
- LEFT ¿11.5 x 580mm K695563 18291108S Arthrodesis Nail
- LEFT ¿11.5 x 580mm K857453 18291108S Arthrodesis Nail
- LEFT ¿11.5 x 580mm K862864 18291108S Arthrodesis Nail
- LEFT ¿11.5 x 580mm K739588 18291108S Arthrodesis Nail
- LEFT ¿11.5 x 580mm K245215 18291108S Arthrodesis Nail
- LEFT ¿11.5 x 580mm K228300 18291112S Arthrodesis Nail
- LEFT ¿11.5 x 620mm K219678 18291112S Arthrodesis Nail
- LEFT ¿11.5 x 620mm K237017 18291112S Arthrodesis Nail
Distribution
Distributed nationwide across the United States.
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