DePuy Orthopaedics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0490-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100

Product Classification:

Class II

Date Initiated: December 7, 2021

Date Posted: January 19, 2022

Recall Number: Z-0490-2022

Event ID: 89240

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

Status: Terminated

Product Quantity: 140 units

Code Information:

Lot #: 9793946, 9793947, 9802315, 9802316, 9802317, 9802318, 9802320, 9813856, 9814516, 9824502, 9824503, 9824505, 9834401, 9834402, 9836078, 9841198, 9880972, 9886688, 9887451, 9887452 GTIN: 10603295004189

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated