FDA recall Z-0308-2020

Product

PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112 00234700114 00234700116 00234700118 00234700206 00234700208 00234700210 00234700212 00234700214 00234700216 00234700218 00234703104 00234703106 00234703108 00234703204 00234703206 00234703208

Reason for recall

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Distribution

Distributed nationwide.

Key facts

Status

Terminated

Initiation date

2019-10-10

Report date

2019-11-13

Termination date

2020-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0308-2020