Z-2348-2021Class II

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080

Name: Z-2348-2021 ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Creator: DePuy Orthopaedics, Inc.
Published: 2021-07-01
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2021-07-01 / Terminated / root cause: labeling and UDI

FDA source

DePuy Orthopaedics, Inc. began a recall of ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080 on 2021-07-01. FDA classified it as Class II and gives the reason as "Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2348-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-01
Posted: 2021-08-25
Terminated: 2023-02-01
Recalling firm: Depuy Orthopaedics Inc.
Product: ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
Root cause tag: labeling and UDI
FDA root cause: Process change control
Action: DePuy Syntheses issued Medical Device Product Recall (Removal) Ref. 1986537 dated 7/1/21. Letter states reason for recall, health risk and action to take: Please take the Following Steps: 1.Examine your inventory immediately to determine if you have the subject lot and quarantine theproduct. 2.Contact your DePuy Synthes Sales Consultant to coordinate the return of any affected devices or callcustomer service following the typical returns process in order to acquire a return number prior toshipping product. 3.Review, complete, sign, and return the attached business response form (page 3 of this letter) to your localDePuy Synthes sales organization in accordance with the directions on the form within 5 business days ofreceipt of this notification. 4.Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport,store, stock, or use the devices subject to this action). 5.If any of the subject lot has been forwarded to another facility, contact that facility and provide them with thisnotice. 6.Post a copy of this notice in a visible area for awareness and keep a copy for your records. Should you have any other inquiries please do not hesitate to contact your DePuy Synthes Sales Consultant.
Quantity in commerce: 7 units
Distribution: International distribution in the countries of Canada, France.
Product codes and lots: Lot Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2348-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2348-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-25

Product code JWH

K160700Class IIATTUNE Revision Knee SystemDepuy(Ireland) / cleared 2016-06-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)