Reported Mar 14, 2018 · Terminated
Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been…
DePuy Orthopaedics, 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: DePuy Orthopaedics, Inc. · 325 Paramount Dr · Raynham, MA · 02767-5199
Is this the product you have?
- Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
- Lot codes and dates
- Product code287804102
- Lot number
122315-B R122315-A R041117A
- Amount recalled
- 130 units total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Potential for Intra-operative breakage of driver tips
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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