CLASS II Device recall · Reported 3 May 2017 · FDA Enforcement Report
K-Wire, Threaded Blunt recalled by Amendia
Amendia is recalling K-Wire, Threaded Blunt, distributed in Georgia, Kansas, Texas. The recall was initiated on 6 Apr 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1885-2017
- FDA event ID
- 77069
- Recalling firm
- Amendia, Marietta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Apr 2017
- FDA classified
- 27 Apr 2017
- Reported
- 3 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Spinal Implants
Timeline
| 6 Apr 2017 | Recall initiated by company | |
| 27 Apr 2017 | Classified by FDA | +21 days |
| 3 May 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
Product as listed by the FDA
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
Where it was distributed
US distribution to GA, KS & TX
Questions about this recall
Is K-Wire, Threaded Blunt recalled?
Yes. Amendia recalled K-Wire, Threaded Blunt on 6 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-1885-2017.
Why was it recalled?
Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
Which lots are affected?
Lot Number 135561
Where was it sold?
US distribution to GA, KS & TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |