Zimmer Biomet Recalls Sterile Shoulder System Drills Due to Fracture Risk
Zimmer Biomet is recalling 2,825 sterile shoulder system drills manufactured with raw material anomalies that may increase the risk of instrument fracture.
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 is classified as FDA Class II and involves a risk-of-harm product (instrument fracture) where no specific injuries or illnesses have been reported in the source text, meeting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 2,825 units of the Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter (Item Number/EDI 47430904601). The recalled sterile 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 various trauma and extremity instruments, including drill bits and screw taps, 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 during use.
Healthcare facilities and distributors should identify and quarantine the affected units. The specific lot numbers subject to this recall are 63399406, 63399407, 63413258, 63418122, 63419454, 63421749, 63471169, 63471170, 63471171, 63474753, 63474754, 63484232, 63501370, 63633540, 63649266, and 63655091.
The recalled product
- Product
- Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 2,825
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 (15)
- Lot Numbers: 63399406
- 63399407
- 63413258
- 63418122
- 63419454
- 63421749
- 63471169
- 63471170
- 63471171
- 63474753
- 63474754
- 63484232
- 63501370
- 63633540
- 63649266 & 63655091.
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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