INBONE STEM, TIBIAL, TOP, Part Number 200011901
Reported: December 4, 2019 Initiated: November 8, 2016 #Z-0565-2020
Product Description
INBONE STEM, TIBIAL, TOP, Part Number 200011901
Reason for Recall
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Details
- Recalling Firm
- Wright Medical Technology, Inc.
- Units Affected
- 65 units
- Distribution
- US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
- Location
- Arlington, TN
Frequently Asked Questions
What product was recalled? ▼
INBONE STEM, TIBIAL, TOP, Part Number 200011901. Recalled by Wright Medical Technology, Inc.. Units affected: 65 units.
Why was this product recalled? ▼
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2019. Severity: Moderate. Recall number: Z-0565-2020.
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