Recall Z-2407-2018— Stryker GmbH
Class II · Terminated
Class II FDA medical device recall by Stryker GmbH, initiated 2018-04-27, terminated 2020-05-21. It names one FDA 510(k) clearance: K003018. Product: Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S. Reason: The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage..
- Recalling firm
- Stryker GmbH
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-27
- Terminated
- 2020-05-21
- Firm location
- Selzach, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
Reason for recall
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
Data sourced from openFDA. This site is unofficial and independent of the FDA.