FDA-Device2015-02-11Class II
Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
Zimmer, Inc.
Hazard
Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; Revision surgery to remove the fractured tip
Sold states
Worldwide distribution: US nationwide, including Puerto Rico, South Korea, Singapore, Dominican Republic, Canada, Japan, and Germany.
Affected count
1,091
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1042-2015Don't want to check this manually?
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