Agency classClass IIOur severity:High FDA (Devices)·Z-1842-2016·Announced 2016-06-08

ConMed Recalls Hip Preservation System PreBent Burs Due to Metal Shavings

ConMed is recalling 991 Hip Preservation System PreBent Burs because an assembly error caused metal shavings to be released during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of harm (metal shavings) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

ConMed Corporation is recalling 991 pieces of the Hip Preservation System Signature Series PreBent Burs. The affected products include the PreBent Spherical Bur (Catalog Number HPS-HB11), PreBent Polishing Bur (Catalog Number HPS-HB12), and PreBent Oval Bur (Catalog Number HPS-HB13). These medical devices are intended for the resection of osseous tissue in arthroscopic and endoscopic surgical procedures.

The recall was initiated because metal shavings are released from the burs during use. This issue is caused by contact between the bur and the hood of the PreBent Bur assembly. The root cause is an assembly error during the manufacturing process that resulted in the inadvertent mixing of two sizes of bearings.

The affected units were distributed nationwide to California, Colorado, Florida, Indiana, Maryland, Minnesota, North Carolina, New York, Ohio, Texas, Utah, and Virginia, as well as internationally to Canada and Wales. Specific lot numbers are listed in the structured product information. No illnesses or injuries are reported in the source text.

The recalled product

Product: Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-HB13 The…
Manufacturer: ConMed Corporation
Category: Medical Device — Surgical Instruments
Hazard: metal-shavings
foreign-object
Affected units: 991

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot Numbers: 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

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Same manufacturer · ConMed Corporation

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Same hazard · metal shavings