Recall Z-0885-2016— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2016-02-16, terminated 2017-02-14. FDA's recall record names no specific 510(k) clearance for this event. Product: HipLOC CHS Plate/Lag Screw Introducer. Reason: A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-16
- Terminated
- 2017-02-14
- Firm location
- Warsaw, IN, United States
Product description
HipLOC CHS Plate/Lag Screw Introducer
Reason for recall
A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.
Data sourced from openFDA. This site is unofficial and independent of the FDA.