Recall Z-1842-2016 ยท GFF Bur, Surgical, General & Plastic Surgery
ConMed Corporation
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
| Date | May 31, 2016 (initiated Dec 21, 2015) |
| Status | Terminated |
| Reason | 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 | 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 largohpshb@conmed.com. The devices should be returned to ConMed Corporation NCR-4 |
| Quantity | 991 pieces |
| Distribution | Worldwide Distribution - Nationwide to CA, CO, FL, IN, MD, MN, NC, NY, OH, TX, UT & VA; International: Canada, Wales |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.