Recall Z-2398-2018— 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: Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S. 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
Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
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.