FDAClass IIOctober 4, 2017

Herbert Cannulated Bone Screw System recall

Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile

Why was Herbert Cannulated Bone Screw System recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 63561678, 63444450 & 63475217.

Product
Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile
Recalling firm
Zimmer Biomet, Inc.
Quantity
18 units
Distribution
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
Recall date
October 4, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls