FDA Medical Device Recalls (openFDA)
DEPUY (IRELAND): Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
- Recall number
- Z-1987-2026
- Recalling firm
- DEPUY (IRELAND)
- Product
- Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
- Status
- Open, Classified
- Initiated
- 2026-04-03
- Posted
- 2026-04-29
- Terminated
- not on file
- Reason
- The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the states of MN, NC, TX.
- Lot, serial or model codes
- Part Number: 150450107. UDI-DI: 10603295533139. Lot Number: 1006440. Expiration Date: 11/30/2035.
- 510(k) numbers
- ["K242871"]
- PMA numbers
- not on file
- Product code
- KRO
- Firm FEI
- 3002854251
- Firm city
- Ringaskiddy Co. Cork
- Firm state
- not on file
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28