X Spine Systems Recalls Calix T PEEK Lumbar System TLIF Rasps
X Spine Systems is recalling 195 units of Calix T PEEK Lumbar System TLIF Rasps because the tools may detach and become lodged in the surgical site.
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 recall is classified as FDA Class II and involves a structural defect where surgical instruments may detach and become lodged in the patient's body, posing a significant risk of injury.
Plain-English summary
X Spine Systems Inc is recalling 195 units of the Calix T PEEK Lumbar System, TLIF Rasp. The affected products include specific sizes (28mm x 10mm x 6mm and 28mm x 10mm x 10mm) and associated part and lot numbers. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is being issued because the trials and rasps used to prepare the surgical site for implant placement may become detached from the inserter assembly part. If this occurs, the detached components may become lodged in the intervertebral space.
The affected products were shipped to 19 U.S. states and Puerto Rico, as well as to Australia, England, Germany, Italy, Mexico, Portugal, and the United Kingdom. Healthcare providers and patients who have used these specific rasps should contact X Spine Systems Inc for further instructions.
The recalled product
- Product
- Calix T PEEK Lumbar System, TLIF Rasp
- Manufacturer
- X Spine Systems Inc
- Affected units
- 195
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 (20)
- Size
- 28mm x 10mm x 6mm
- Part #:
- X034-0360
- Lot #:
- 23515
- 23516
- 24295
- 24836
- 24836s1
- 24836S2
- 657001
- 760913 & Size
- 28mm x 10mm x 10mm
- X034-0364
- 23517
- 23518
- 24296
- 24837
- 657002
Distribution
Part of a larger recall action
This product is one of 4 recalled by X Spine Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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