Z-2401-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2018
- Initiation Date
- April 27, 2018
- Termination Date
- May 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
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.
Distribution Pattern
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
Code Information
GTIN: 04546540200693; Lot code: K08327F