Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
Reported: June 3, 2020 Initiated: April 17, 2020 #Z-2146-2020
Product Description
Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
Reason for Recall
Potential presence of elevated endotoxin levels that exceed the specification limit
Details
- Recalling Firm
- Biomet, Inc.
- Units Affected
- 15 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis. Recalled by Biomet, Inc.. Units affected: 15 units.
Why was this product recalled? ▼
Potential presence of elevated endotoxin levels that exceed the specification limit
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2020. Severity: Moderate. Recall number: Z-2146-2020.
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