Device product
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
Z-1885-2017
Product summary
- Firm
- Amendia, Inc
- Event
- Event 77069
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-1885-2017
Official wording
Reason: Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
Code information: Lot Number 135561
Distribution pattern: US distribution to GA, KS & TX
Derived failure modes
-
Labeling or packaging
Mislabeled