High FDA (Devices)·Z-2016-2012·Announced 2012-07-25

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.

What this means for you

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 of
Manufacturer: Stryker Howmedica Osteonics Corp.
Category: Medical Device — Orthopedic Implants
Hazard: sterile-barrier-breach
infection-risk
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.

Same manufacturer · Stryker Howmedica Osteonics Corp.

See all →

High
Stryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk
FDA (Devices) · 2017-05-31
Severe
Stryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage
FDA (Devices) · 2017-01-18
Moderate
Stryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2016-12-28
Severe
Stryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure
FDA (Devices) · 2016-11-16
High
Stryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor
FDA (Devices) · 2016-10-19

Same hazard · sterile barrier breach