FDA-Device2020-11-11Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-26
Zimmer Biomet, Inc.
Hazard
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Sold states
US Nationwide
Affected count
412 units total
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-26
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0338-2021Don't want to check this manually?
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