Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Reported: June 17, 2020 Initiated: May 14, 2020 #Z-2304-2020
Product Description
Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Reason for Recall
Distributed to the field without having completed design history files or design transfer activities
Details
- Recalling Firm
- Biomet
- Units Affected
- 10 OUS
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.. Recalled by Biomet. Units affected: 10 OUS.
Why was this product recalled? ▼
Distributed to the field without having completed design history files or design transfer activities
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2304-2020.
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