Reported Sep 18, 2013 · Terminated
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902.…
Spine Wave, 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: Spine Wave, Inc. · 3 Enterprise Dr Ste 302 · Shelton, CT · 06484-4694
Is this the product you have?
- StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
- Lot codes and dates
- Lot Numbers272L08 and 272L09
- Amount recalled
- 17 units
Where it was sold
Why it was recalled
A component Superior endplate manufactured from a different polymer than specified
This product could cause temporary or reversible health problems — stop using it.
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