Recall Z-1885-2017 ยท LXH Orthopedic Manual Surgical Instrument
Amendia, Inc
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
| Date | Apr 25, 2017 (initiated Apr 6, 2017) |
| Status | Terminated |
| Reason | Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol. |
| Root cause | Process design |
| Action | Amendia sent an Urgent Medical Device Recall Letter dated April 6, 2017, and April 25, 2017, to all affected customers. The letter requested that they check inventory, quarantine product for return to Amendia, and requested a sub-recall. The letter also included a reply form to be returned to Amendia. Customers with questions were instructed to call Amendia Customer Service at 770-575-5224. For questions regarding this recall call 404-610-7215. |
| Quantity | 15 units |
| Distribution | US distribution to GA, KS & TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.