Zimmer Biomet Recalls Orthopedic Surgical Instruments Due to Fracture Risk
Zimmer Biomet is recalling 21 units of M/DN Intramedullary Fixation Femoral Drills because raw material anomalies may cause the instruments to fracture during use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (risk of instrument fracture) in a medical device used during surgery, which aligns with the rubric criteria for a Severe rating.
Plain-English summary
Zimmer Biomet, Inc. is recalling 21 units of M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm (Item Number/EDI 00225503550, 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 specific lot number for the recalled items is 63329859.
The recall was initiated because the instruments were manufactured from raw material with an anomaly. This anomaly may be located on or below the surface of the instrument and can increase the risk of the instrument fracturing during use.
Healthcare facilities and distributors should stop using the affected instruments and contact Zimmer Biomet for instructions on how to return or dispose of the products.
The recalled product
- Product
- M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550, Nonsterile. orthopedic surgical instrument.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 21
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 (1)
- Lot Number: 63329859
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