Hip Preservation System Signature Series PreBent Burs under the… — Class II medical device recall Z-1842-2016

Terminated recall by ConMed Corporation, reported 2016-06-08, distributed nationwide. Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bu

Recall number	`Z-1842-2016`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	ConMed Corporation, Utica, NY, United States
Recall initiated	2015-12-21
Classified	2016-05-31
Reported by FDA	2016-06-08
Terminated	2018-05-24
Distributed	Nationwide (US)
Countries outside the US	CA
Quantity	991 units
Reason classes	foreign material
Model numbers	`HPS-HB11`, `HPS-HB12`, `HPS-HB13`

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 ConMed Hip Preservation System Signature Series is intended to be used for resection of osseous tissue (bone) in arthroscopic and endoscopic surgical procedures

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1842-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.