FDA recall Z-0331-2021

Product

ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-28

Reason for recall

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.

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2020-09-24

Report date

2020-11-11

Termination date

2022-05-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0331-2021