FDA-Device2019-12-04Class II
ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
Wright Medical Technology, Inc.
Hazard
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Sold states
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Affected count
40 units
Manufactured in
11576 Memphis Arlington Rd, Arlington, TN, United States
Products
ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0563-2020Don't want to check this manually?
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