Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits
Zimmer Biomet is recalling 3,640 ECT Internal Fracture Fixation Drill Bits because raw material anomalies may increase the risk of instrument fracture during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (instrument fracture) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 3,640 units of ECT Internal Fracture Fixation Drill Bits, 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802006, Nonsterile. These orthopedic surgical instruments were distributed nationwide in the United States and internationally to Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan, and Trinidad.
The recall was initiated because the drill bits were manufactured from raw material with an anomaly. This anomaly may be on or below the surface and can increase the risk of instrument fracture. The affected units are identified by specific lot numbers listed in the recall documentation.
Healthcare facilities and distributors should stop using the affected drill bits and contact Zimmer Biomet for instructions on return or replacement. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item Number/EDI 00231802006, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 3,640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: 63535521
- 63535522
- 63535523
- 63535524
- 63545285
- 63562130
- 63578154
- 63578156
- 63358058
- 63358059
- 63358060
- 63358061
- 63364050
- 63377480
- 63377481
- 63377482
- 63384605
- 63384606
- 63384607
- 63398721
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 60 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 60 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · instrument fracture
See all →- HighZimmer Biomet Recalls 1.0mm Drill Bits Due to Fracture Risk
FDA (Devices) · 2018-02-14
- HighZimmer Biomet Recalls Herbert Cannulated Bone Screw System Drills
FDA (Devices) · 2017-10-04
- HighZimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
FDA (Devices) · 2017-10-04
- SevereZimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
FDA (Devices) · 2017-10-04
- HighZimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
FDA (Devices) · 2017-10-04