FDAFDA · Food and drugs·Recall number Z-1885-2017
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
Published May 3, 2017 · Recall initiated: April 6, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Amendia, Inc
- Distributor
- US distribution to GA, KS & TX
- Lot
- Lot Number 135561
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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