Recall Z-0493-2014— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2013-11-26, terminated 2014-09-29. FDA's recall record names no specific 510(k) clearance for this event. Product: G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000. Reason: Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-26
- Terminated
- 2014-09-29
- Firm location
- Warsaw, IN, United States
Product description
G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Reason for recall
Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.