Cortera Spinal Fixation System screws recalled for incorrect dimensions
XTANT Medical is recalling Cortera Spinal Fixation System screws that were manufactured with incorrect dimensions. Screws labeled 8.5 mm by 50 mm are actually 5.5 mm by 45 mm, potentially preventing proper screw engagement.
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: This is an FDA Class II medical device recall involving incorrect screw dimensions that may prevent proper engagement. No hospitalizations or injuries have been reported, making this a risk-of-harm product without reported injury, which corresponds to severity 3 per rubric criteria.
Plain-English summary
XTANT Medical Holdings, Inc. is recalling Cortera Spinal Fixation System screws (Reference 150100-85050, Lot AP23000143) distributed in Michigan. The spinal fixation screws were labeled as 8.5 mm in diameter and 50 mm in length, but were manufactured using an incorrect screw shank component.
The affected screws were actually manufactured as 5.5 mm in diameter and 45 mm in length. If used in surgical procedures, these incorrect dimensions may prevent the screws from engaging properly, potentially compromising the stability of the spinal fixation.
Six units of the affected lot were distributed in Michigan. Healthcare providers and patients who may have received this product should contact XTANT Medical Holdings, Inc. regarding their specific situation.
The recalled product
- Product
- Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
- Manufacturer
- XTANT Medical Holdings, Inc
- Category
- Medical Device — Spinal Fixation
- Affected units
- 6
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)
- UDI-DI: 00810076564005
- Lot: AP23000143
Distribution
Distributed in 1 state:
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