Z-1419-2022Class II

ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in...

Name: Z-1419-2022 ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in...
Creator: DePuy Orthopaedics, Inc.
Published: 2022-06-29
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2022-06-29 / Open, Classified / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of 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 on 2022-06-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1419-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-29
Posted: 2022-07-20
Recalling firm: Depuy Orthopaedics Inc.
Product: 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 code: HWT Template
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DePuy Synthes issued Urgent Medical Device Correction Letter on June 29 2022. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately for the subject lots and quarantine the products. 2. To minimize disruption, replacement of the spring will be completed by a Field Service Representative. You will be contacted directly by a member of the Field Service Team. 3. Familiarize yourself with the content of this letter and forward this notice to any personnel in your facility who need to be informed. 4. Complete all fields, sign, and return the attached business response form (BRF) on the last page of this letter to [email protected] within three (3) business days of receipt of this medical device correction letter. Please include FA 2126657 - Attune Measured Sizing & Rotation Guide in the email subject line. 5. Complete the BRF even if you do not have any of the subject product in your current inventory. 6. If any of the subject product has been forwarded to another facility, contact that facility, and provide a copy of this notice to the relevant personnel. 7. Post a copy of this notice in a visible area for awareness of this correction. Contact your local DePuy Synthes Sales Consultant. For Medical Information Requests, please visit our website: https://www.jnjmedicaldevices.com/mir
Quantity in commerce: 872 units
Distribution: 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
Product codes and lots: GTIN: 10603295434061 Lots: AB4536235, AB4733296, AB4841493, AB4810808, AB4841495, AB4904565, AB4967214, AB5004557, and AB5034303

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1419-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1419-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-27	2022-07-20

Product code HWT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)