A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
FDA device recall Z-2072-2015 · posted 2015-07-14 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- 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.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- HYA
- Quantity affected
- 223
- Distribution
- Domestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica
- Date initiated
- 2015-06-17
- Date posted
- 2015-07-14
- Date terminated
- 2016-03-22
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.