Stryker T2 Alpha Delta Strike Plate Recalled for Breakage Risk
Stryker GmbH is recalling T2 Alpha Delta Strike Plate instruments because they can break during nail implantation or removal, potentially causing complications.
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 and involves a structural defect (breakage) in a medical device that can lead to complications during surgical procedures, meeting the criteria for a Severe rating.
Plain-English summary
Stryker GmbH is recalling the Stryker T2 Alpha Delta Strike Plate IMN Instruments, catalog number 2351-0050. These instruments are part of the IMN Instruments System and are used to support the insertion and withdrawal of nails through the Targeting Device. The recall involves 433 units, with 289 units distributed in the United States and 144 units distributed outside the U.S. in Switzerland, France, Spain, the United Kingdom, Italy, Sweden, the Netherlands, and Australia.
The recall is being issued because the instrument can break at the level of the thread when exposed to high forces during nail implantation or removal. This breakage can lead to complications during the insertion and removal of nails. The agency has classified this recall as Class II.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker GmbH for instructions on return or replacement. Patients who have had these instruments used during a procedure should contact their healthcare provider if they experience any complications.
The recalled product
- Product
- Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050
- Manufacturer
- Stryker GmbH
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 (1)
- All lots UDI: (01)07613327350210
Distribution
Distributed nationwide across the United States.
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