Class II recallOngoing

DePuy Synthes ATTUNE Knee System recall — FDA event 98707

FDA · FDA event 98707 · Posted Apr 29, 2026

Published Apr 29, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

Depuy Ireland notified consignees on about 04/03/2026 via email. Consignees were instructed to examine inventory for affected units and immediately quarantine them, arrange for the return of all affected units, and complete and return the provided Business Response Form. Consignees were also instructed to forward the notification letter to anyone within each facility that needs to be informed, notify customers if affected units were further distributed and post a copy of the notification letter in a visible area for awareness.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This record references DePuy Synthes ATTUNE Knee System by DePuy Synthes.

Products affected by FDA event 98707
Model	Description	Lot / serial range	Manufactured	Status
Z-1988-2026	Z-1988-2026	Part Number: 150450108. UDI-DI: 10603295543022. Lot Number: AF1006441. Expiration Date: 12/31/2035.	Not provided in the normalized record	Ongoing
Z-1991-2026	Z-1991-2026	Part Number: 150450205. UDI-DI: 10603295533160. Lot Number: 1006444. Expiration Date: 10/31/2035.	Not provided in the normalized record	Ongoing
Z-1986-2026	Z-1986-2026	Part Number: 150450105. UDI-DI: 10603295533122. Lot Number: AF1007829. Expiration Date: 12/31/2035.	Not provided in the normalized record	Ongoing
Z-1990-2026	Z-1990-2026	Part Number: 150450204. UDI-DI: 10603295533153. Lot Number: 1005229. Expiration Date: 10/31/2035.	Not provided in the normalized record	Ongoing
Z-1989-2026	Z-1989-2026	Part Number: 150450203. UDI-DI: 10603295533146. Lot Number: 1007537. Expiration Date: 10/31/2035.	Not provided in the normalized record	Ongoing
Z-1992-2026	Z-1992-2026	Part Number: 150450207. UDI-DI: 10603295533177. Lot Number: 1007046. Expiration Date: 10/31/2035.	Not provided in the normalized record	Ongoing
Z-1985-2026	Z-1985-2026	Part Number: 150450104. UDI-DI: 10603295533115. Lot Number: 1007844. Expiration Date: 11/30/2035	Not provided in the normalized record	Ongoing
Z-1987-2026	Z-1987-2026	Part Number: 150450107. UDI-DI: 10603295533139. Lot Number: 1006440. Expiration Date: 11/30/2035.	Not provided in the normalized record	Ongoing
Z-1993-2026	Z-1993-2026	Part Number: 150450208. UDI-DI: 10603295543039. Lot Numbers: AF1008441, AF1008028. Expiration Date: 12/31/2035.	Not provided in the normalized record	Ongoing

Distribution: US Nationwide distribution in the states of MN, NC, TX.
Units affected: See official FDA record
Category: Knee implants

Timeline

Apr 3, 2026
Recall initiated
Date recorded by the FDA.
Apr 29, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Loading MedWatcher information…

DePuy Synthes ATTUNE Knee System recall — FDA event 98707

FDA · FDA event 98707 · Posted Apr 29, 2026

Published Apr 29, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

Products affected by FDA event 98707
Model	Description	Lot / serial range	Manufactured	Status
Z-1988-2026	Z-1988-2026	Part Number: 150450108. UDI-DI: 10603295543022. Lot Number: AF1006441. Expiration Date: 12/31/2035.	Not provided in the normalized record	Ongoing
Z-1991-2026	Z-1991-2026	Part Number: 150450205. UDI-DI: 10603295533160. Lot Number: 1006444. Expiration Date: 10/31/2035.	Not provided in the normalized record	Ongoing
Z-1986-2026	Z-1986-2026	Part Number: 150450105. UDI-DI: 10603295533122. Lot Number: AF1007829. Expiration Date: 12/31/2035.	Not provided in the normalized record	Ongoing
Z-1990-2026	Z-1990-2026	Part Number: 150450204. UDI-DI: 10603295533153. Lot Number: 1005229. Expiration Date: 10/31/2035.	Not provided in the normalized record	Ongoing
Z-1989-2026	Z-1989-2026	Part Number: 150450203. UDI-DI: 10603295533146. Lot Number: 1007537. Expiration Date: 10/31/2035.	Not provided in the normalized record	Ongoing
Z-1992-2026	Z-1992-2026	Part Number: 150450207. UDI-DI: 10603295533177. Lot Number: 1007046. Expiration Date: 10/31/2035.	Not provided in the normalized record	Ongoing
Z-1985-2026	Z-1985-2026	Part Number: 150450104. UDI-DI: 10603295533115. Lot Number: 1007844. Expiration Date: 11/30/2035	Not provided in the normalized record	Ongoing
Z-1987-2026	Z-1987-2026	Part Number: 150450107. UDI-DI: 10603295533139. Lot Number: 1006440. Expiration Date: 11/30/2035.	Not provided in the normalized record	Ongoing
Z-1993-2026	Z-1993-2026	Part Number: 150450208. UDI-DI: 10603295543039. Lot Numbers: AF1008441, AF1008028. Expiration Date: 12/31/2035.	Not provided in the normalized record	Ongoing

Distribution

US Nationwide distribution in the states of MN, NC, TX.

Units affected

See official FDA record

DePuy Synthes ATTUNE Knee System recall — FDA event 98707

Follow DePuy Synthes ATTUNE Knee System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

DePuy Synthes ATTUNE Knee System recall — FDA event 98707

Follow DePuy Synthes ATTUNE Knee System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline