Reported Oct 26, 2016 · Terminated
Calix T PEEK Lumbar System, TLIF Trial
X Spine Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: X Spine Systems Inc · 452 Alexandersville Rd · Miamisburg, OH · 45342-3658
Is this the product you have?
- Calix T PEEK Lumbar System, TLIF Trial
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 Size, 28mm x 10mm x 6mm, Part #:, X034-0340, Lot #:, 118501, 23502, 23503, 24284, 24291, 24825, 24825s1, 24825S2, 760902 2 Size, 28mm x 10mm x 7mm, Part #:, X034-0341, Lot #:, 118502, 23504, 24285, 24826, 24826S1, 24826S2, 760903 3 Size, 28mm x 10mm x 8mm, Part #:, X034-0342, Lot #:, 118503, 23505, 24286, 24827, 24827S1, 24827S2, 760904 4 Size, 28mm x 10mm x 9mm, Part #:, X034-0343, Lot #:, 118504, 23506, 24287, 24828, 24828S1, 24828S2, 760905 5 Size, 28mm x 10mm x 10mm, Part #:, X034-0344, Lot #:, 118505, 23507, 24288, 24829, 24829S1, 24829S2, 760906 6 Size, 28mm x 10mm x 11mm, Part #:, X034-0345, Lot #:, 118506, 23508, 24289, 24830, 24830S1, 24830S2, 760907 7 Size, 28mm x 10mm x 12mm, Part #:, X034-0346, Lot #:, 118507, 23509, 24290, 24831, 24831S1, 24831s2, 760908 8 Size, 28mm x 10mm x 13mm, Part #:, X034-0347, Lot #:, 118508, 23510, 24291, 24832, 24832s1, 24832S2, 760909 9 Size, 28mm x 10mm x 14mm, Part #:, X034-0348, Lot #:, 118509, 23511, 24292, 24833, 760910 10 Size, 28mm x 10mm x 15mm, Part #:, X034-0349, Lot #:, 118510, 23512, 24293, 24293-R, 24834, 760911 & Size, 28mm x 10mm x 16mm, Part #:, X034-0350, Lot #:, 118511, 23513, 23514, 24294, 24835, 24835S1, 24835S2, 32513, 760912. - Amount recalled
- 1186 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral space.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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