Z-1885-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 3, 2017
- Initiation Date
- April 6, 2017
- Termination Date
- May 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product Description
01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery
Reason for Recall
Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
Distribution Pattern
US distribution to GA, KS & TX
Code Information
Lot Number 135561