FDA Recalls Piranha Cervical Spine Screws Due to Incorrect Length Marking
The FDA is recalling 82 Piranha screws used in cervical spine surgery because some units marked as 12 mm actually measure 14 mm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could lead to improper surgical fixation (risk-of-harm product), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Amendia, Inc dba Spinal Elements is recalling 82 units of the Piranha Screw 4.0 x 12mm (Part No. CSF-40-12, Lot No. 132635). These screws are used in the Piranha Surgical Plate System, which is intended to provide stabilization of the cervical vertebrae (C2-C7) for conditions such as degenerative disc disease, spondylolisthesis, spinal stenosis, tumors, and trauma.
The recall is due to potential incorrect marking and color identification. Specifically, some screws marked as 12 mm actually measure 14 mm. This discrepancy could lead to the use of an incorrect screw size during surgery.
The affected units were distributed in the United States to the states of Arkansas, California, Georgia, Louisiana, Maryland, Nevada, New York, Ohio, and Texas. Healthcare providers and patients who have received this specific lot of screws should contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Amendia, Inc dba Spinal Elements
- Affected units
- 82
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part No. CSF-40-12
- Lot No. 132635
Distribution
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