Recall Z-1021-2015 ยท HXW Bender
Synthes, Inc.
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
| Date | Jan 28, 2015 (initiated Dec 15, 2014) |
| Status | Terminated |
| Reason | Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located. |
| Root cause | Finished device change control |
| Action | An Urgent Notice: Medical Device Recall, dated December 19, 2014, was sent to end users and sales consultants that described the product, problem, and action to be taken. End users/sales staff were requested to immediately stop use and remove affected product from inventory. Customers were asked to call and obtain a Return Authorization Number, and complete and return the Verification Section of the letter along with the devices to Synthes per the instructions provided. Questions should be directed to 610-719-5450 or your local DePuy Synthes sales consultant. |
| Quantity | 973 |
| Distribution | Worldwide Distribution -- US and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.