DePuy Orthopaedics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1419-2022)

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:

ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525

Product Classification:

Class II

Date Initiated: June 29, 2022

Date Posted: July 27, 2022

Recall Number: Z-1419-2022

Event ID: 90557

Reason for Recall:

Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain

Status: Ongoing

Product Quantity: 872 units

Code Information:

GTIN: 10603295434061 Lots: AB4536235, AB4733296, AB4841493, AB4810808, AB4841495, AB4904565, AB4967214, AB5004557, and AB5034303

Distribution Pattern:

Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam

Voluntary or Mandated:

Voluntary: Firm initiated