Recall Z-2072-2015
Biomet, Inc. · initiated June 17, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
Codes / lots: Part Number: 816301006 Lot Numbers: 099216, 093776, 093717, 093716, 088526, 081179, 072525, 072524
Reason for recall
Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.
FDA-determined cause: Vendor change control
Action taken
On 6/17/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for locating and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Details
- Recall number
- Z-2072-2015
- Initiated
- June 17, 2015
- Posted by FDA
- July 14, 2015
- Terminated
- March 22, 2016
- Product code
- HYA – Forceps, Wire Holding
- Quantity
- 223
- Distribution
- Domestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica
- Recalling firm
- Biomet, Inc., Warsaw, IN