Recall Z-0336-2020— Zimmer Biomet, Inc.

Name: FDA recall Z-0336-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-10

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2019-10-10, terminated 2020-05-19. It names one FDA 510(k) clearance: K071535. Product: Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004. Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration)..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-10-10
Terminated: 2020-05-19
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K071535 — BIOLOX DELTA CERAMIC FEMORAL HEADZimmer, Inc.·cleared 2007-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.