fastener, fixation, nondegradable, soft tissue
Reported: March 21, 2018 Initiated: October 25, 2017 #Z-1009-2018
Product Description
fastener, fixation, nondegradable, soft tissue
Reason for Recall
It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 429 units
- Distribution
- TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
fastener, fixation, nondegradable, soft tissue. Recalled by Zimmer Biomet, Inc.. Units affected: 429 units.
Why was this product recalled? ▼
It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 21, 2018. Severity: Moderate. Recall number: Z-1009-2018.
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