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FDA (Device enforcement)Recalled 2019-12-05closedclass ii

Stryker GmbH: 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 Num

Is my product affected?

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

  • UPC 07613327350210

Check against the official notice below — it lists the full affected range.

What happened

Stryker GmbH is recalling the T2 Alpha Delta Strike Plate IMN Instruments, which are part of the IMN Instruments System used to support insertion and withdrawal of nails through the Targeting Device. The instrument can break at the thread level when exposed to high forces during nail implantation or removal, which may lead to complications during these procedures.

The recall affects 433 units worldwide, including 289 units in the United States and 144 units in Switzerland, France, Spain, the United Kingdom, Italy, Sweden, the Netherlands, and Australia. All lots are identified by UDI (01)07613327350210. The source document does not specify a remedy or action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal.

Details from the source

Reason for recall: Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal. Distribution: Worldwide distribution - US Nationwide distribution and countries of Switzerland, France, Spain, United Kingdom, Italy, Sweden, Netherlands, Australia. Quantity: 433 (289 units U.S. / 144 units OUS) Lot/code info: All lots UDI: (01)07613327350210

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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