Reported Jun 11, 2014 · Terminated
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body…
Synthes, 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: Synthes, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).
- Lot codes and dates
Product no. 03.807.507lot no. 8029684and product no. 03.807.508lot no. 8029689
- Amount recalled
- 3
Where it was sold
Why it was recalled
Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.
This product could cause temporary or reversible health problems — stop using it.
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