Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm

FDA device recall Z-1842-2016 · posted 2016-05-31 · Terminated

Recall details

Recalling firm

ConMed Corporation

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.

Action taken

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 largohpshb@conmed.com. 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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

GFF

Quantity affected

991 pieces

Distribution

Worldwide Distribution - Nationwide to CA, CO, FL, IN, MD, MN, NC, NY, OH, TX, UT & VA; International: Canada, Wales

Date initiated

2015-12-21

Date posted

2016-05-31

Date terminated

2018-05-24

Location

Utica, NY