X Spine Systems Recalls Calix T PEEK Lumbar System Trial Devices
X Spine Systems is recalling 1,186 Calix T PEEK Lumbar System trial devices because components may detach and lodge in the intervertebral space during surgery.
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. The hazard involves a structural defect where surgical components may detach and lodge in the intervertebral space, posing a significant risk of injury during a surgical procedure.
Plain-English summary
X Spine Systems Inc is recalling 1,186 units of the Calix T PEEK Lumbar System, TLIF Trial. The recall involves specific sizes and lot numbers of the trial devices used in spinal surgery.
The recall was initiated because the trials and rasps used to prepare the surgical site for implant placement may become detached from the inserter assembly. 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 should contact X Spine Systems for instructions on how to proceed with the recall.
The recalled product
- Product
- Calix T PEEK Lumbar System, TLIF Trial
- Manufacturer
- X Spine Systems Inc
- Affected units
- 1,186
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 #:
- X034-0340
- Lot #:
- 118501
- 23502
- 23503
- 24284
- 24291
- 24825
- 24825s1
- 24825S2
- 760902
- 28mm x 10mm x 7mm
- X034-0341
- 118502
- 23504
- 24285
- 24826
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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