Z-0074-2022Class II

ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001

Name: Z-0074-2022 ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Creator: DePuy Orthopaedics, Inc.
Published: 2021-09-09
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2021-09-09 / Terminated / root cause: packaging

FDA source

DePuy Orthopaedics, Inc. began a recall of ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001 on 2021-09-09. FDA classified it as Class II and gives the reason as "Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0074-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-09
Posted: 2021-10-07
Terminated: 2023-08-09
Recalling firm: Depuy Orthopaedics Inc.
Product: ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: DePuy (Ireland) issued Urgent Medical Device Recall (Removal)letter via email to US Sales Offices/Distributors and US Hospitals on 9/9/21. Recall letters will be emailed to US Sales Offices/Distributors. US Hospitals will be contacted by sales consultants. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have the subject lot and quarantine the product. 2. Return the subject product(s) using the normal returns process. Work with your sales consultant to return subject product(s) and to replace. To receive replacement product(s) or reimbursement, customers must return the products subject to this removal. 3. Review, complete all fields, sign, and return the attached business response form (BRF) on page 2 of this letter to [email protected] within three (3) business days of receipt of this Removal Letter. Please include in the email subject: FA 2010228 - ATTUNE Revision Tibial Augment Incorrect Screw Size Packaged. 4. Forward this Removal Letter to any personnel in your facility who need to be informed. 5. If any of the product(s) subject to this Removal have been forwarded to another facility, contact that facility and provide a copy of this Removal Letter to the relevant personnel. 6. Post a copy of this Removal Letter in a visible area for awareness of this Removal. If you have any questions, please contact your local DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.
Quantity in commerce: 10 units
Distribution: US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.
Product codes and lots: Lot Number: J6304Z GTIN: 10603295057642

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0074-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0074-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-07

Product code JWH

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)