Recall Z-3145-2017— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-05-22, terminated 2019-03-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile. Reason: Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-22
- Terminated
- 2019-03-29
- Firm location
- Warsaw, IN, United States
Product description
Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile
Reason for recall
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Data sourced from openFDA. This site is unofficial and independent of the FDA.