Z-1842-2016Class II

Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur...

Name: Z-1842-2016 Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur...
Creator: ConMed Corporation
Published: 2015-12-21
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2015-12-21 / Terminated / root cause: manufacturing process

FDA source

ConMed Corporation began a recall of 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... on 2015-12-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1842-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-21
Posted: 2016-05-31
Terminated: 2018-05-24
Recalling firm: ConMed Corporation
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
Product code: GFF Bur, Surgical, General & Plastic Surgery
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.
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
Action: ConMed sent an Urgent Medical Device Recall Notification letter dated December 17, 2015, to all affected customers. Customers are urged to stop use and return these devices immediately. Customers who have further distributed these items are urged to contact all of those organizations immediately and provide a copy of the recall notification letter. It is imperative that all end users of these devices receive the recall notice and respond immediately. Customers with questions can call 315-624-3237 or email [email protected]. The devices should be returned to ConMed Corporation NCR-47057 11155 Concept Blvd. Largo, FL 33773. For questions regarding this recall call 315- 624-3533.
Quantity in commerce: 991 pieces
Distribution: Worldwide Distribution - Nationwide to CA, CO, FL, IN, MD, MN, NC, NY, OH, TX, UT & VA; International: Canada, Wales
Product codes and lots: 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, 583736, 583742, 587514, 627923, 659317 & 664751.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1842-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1842-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31

Product code GFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)