Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits
Zimmer Biomet is recalling 1,558 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, which aligns with the High severity criteria in the rubric.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,558 units of ECT Internal Fracture Fixation Drill Bits, 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, 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 lot numbers are: 63545279, 63610791, 63641572, 63333729, 63333730, 63333732, 63340531, 63364064, 63364065, 63372902, 63384626, 63384629, 63444670, 63444671, 63457776, 63457945, 63462343, 63462344, 63474390, 63497205, 63497206, 63505362, 63510815, 63535517, 63535518, and 63722007.
Healthcare providers and facilities should stop using these specific drill bits and contact Zimmer Biomet for instructions on returning the affected units. 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 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,558
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: 63545279
- 63610791
- 63641572
- 63333729
- 63333730
- 63333732
- 63340531
- 63364064
- 63364065
- 63372902
- 63384626
- 63384629
- 63444670
- 63444671
- 63457776
- 63457945
- 63462343
- 63462344
- 63474390
- 63497205
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.
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