Recall Z-0483-2022— DePuy Orthopaedics, Inc.

Name: FDA recall Z-0483-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-07

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2021-12-07, terminated 2024-05-17. It names 2 FDA 510(k) clearances: K170748, K101996. Product: GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610. Reason: Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage.

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-12-07
Terminated: 2024-05-17
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K170748 — GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC·cleared 2018-01-11
K101996 — DEPUY GLOBAL UNITE SHOULDER SYSTEMDepuy(Ireland)·cleared 2010-12-15

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

GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610

Reason for recall

Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

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