Recall Z-0780-2020— Stryker GmbH
Class II · Terminated
Class II FDA medical device recall by Stryker GmbH, initiated 2019-12-05, terminated 2020-10-09. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..
- Recalling firm
- Stryker GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-05
- Terminated
- 2020-10-09
- Firm location
- Selzach, N/A, Switzerland
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.