CLASS II Device recall · Reported 20 Dec 2017 · FDA Enforcement Report
Piranha Screw 4.0, used in Piranha Surgical Plate System recalled
Amendia is recalling Piranha Screw 4.0, used in Piranha Surgical Plate System The Piranha Surgical Plate, distributed in 9 states. The recall was initiated on 13 Nov 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-0239-2018
- FDA event ID
- 78592
- Recalling firm
- Amendia, Marietta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Nov 2017
- FDA classified
- 13 Dec 2017
- Reported
- 20 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 13 Nov 2017 | Recall initiated by company | |
| 13 Dec 2017 | Classified by FDA | +30 days |
| 20 Dec 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Product as listed by the FDA
Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).
Where it was distributed
US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.
ArkansasCaliforniaGeorgiaLouisianaMarylandNevadaNew YorkOhioTexas
Questions about this recall
Why was it recalled?
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Which lots are affected?
Part No. CSF-40-12, Lot No. 132635
Where was it sold?
US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Amendia
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|---|---|---|---|---|---|
| Device | CLASS II | Mac Pin Non-Cannulated Screw recalled by Amendia | Amendia | Labeling Errors | GA |
| Device | CLASS II | Ceres Self-Drilling Variable Screw 4.0 The Ceres screws recalled | Amendia | Other | 6 states |
| Device | CLASS II | K-Wire, Threaded Blunt recalled by Amendia | Amendia | Labeling Errors | GA, KS, TX |
| Device | CLASS II | Ceres-C Standalone Cervical Interbody The product recalled by Amendia | Amendia | Other | GA |
| Device | CLASS II | Black Widow Plate recalled by Amendia | Amendia | Other | Nationwide |
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 |