Reported Jun 8, 2016 · Terminated
Hip Preservation System Signature Series PreBent Burs under the following labels
ConMed Corporation
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: ConMed Corporation · 525 French Rd · Utica, NY · 13502-5945
Is this the product you have?
Hip Preservation System Signature Series PreBent Burs under the following labels
3 of 3 products
| Model / number | Product as published |
|---|---|
HPS-HB11 | PreBent Spherical Bur, 5.5mm x 19cm |
HPS-HB12 | PreBent Polishing Bur, 5.5mm x 19cm and |
HPS-HB13 | PreBent Oval Bur, 6.0mm x 19cm The ConMed Hip Preservation System Signature Series is intended to be used for resection of osseous tissue (bone) in arthroscopic and endoscopic surgical procedures |
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 569449, 577583, 577969, 579655, 580365, 581176, 581198, 582216, 587320, 594569, 658219, 669615, 673913 & 688136 2 569462, 577800, 577971 & 579652 3 569468, 577835, 577974, 579650, 583736, 583742, 587514, 627923, 659317 & 664751. - Amount recalled
- 991 pieces
Where it was sold
Why it was recalled
Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly. During the manufacturing process an assembly error occurred which caused inadvertent mixing of two sizes of bearings.
This product could cause temporary or reversible health problems — stop using it.
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