Medicrea TLIF-B Holder Recalled Due to Potential Rod Separation
Medicrea International is recalling 14 units of TLIF-B Holders because the inner draw rod may separate from the knob.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall involving a structural defect in a medical device, which aligns with the rubric criteria for a Severe rating.
Plain-English summary
Medicrea International is recalling 14 units of the TLIF-B Holder, short, intended for intervertebral body fusion devices (Catalog Number A24200010). The affected units are identified by Lot Numbers l9B0570 and 19B0572.
The recall is being issued because the inner draw rod, which threads into the cage, may potentially be separated from the proximal knob of the inserter. This defect could compromise the integrity of the device during use.
The recalled products were distributed in Ohio and Virginia. Healthcare providers and facilities that have received these specific units should stop using them and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
- Manufacturer
- Medicrea International
- Affected units
- 14
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)
- Lot Numbers l9B0570
- 19B0572
Distribution
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