ECT Internal Fracture Fixation Drill Bits 3.2 mm recall
ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile. orthopedic surgical instrument.
Why was ECT Internal Fracture Fixation Drill Bits 3.2 mm 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: 63556703, 63566220, 63593926, 63593928, 63593930, 63630281, 63340536, 63340537, 63347015, 63347018, 63347022, 63347034, 63358186, 63358201, 63372867, 63398739, 63398761, 63398762, 63426475, 63426476, 63426478, 63431754, 63431755, 63457862, 63457863, 63457865, 63457889, 63474135, 63479010, 63479011, 63479013, 63524442, 63524443 & 63524445.
- Product
- ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile. orthopedic surgical instrument.
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 2,038 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)