Z-0318-2027

Evos 3.5Mm Lateral Proximal Tibia Plate 6 Hole Left 91Mm Ref72463106

Name: Z-0318-2027 Evos 3.5Mm Lateral Proximal Tibia Plate 6 Hole Left 91Mm Ref72463106
Creator: Smith & Nephew, Inc.
Published: 2026-09-06
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2026-09-06 / Open, Classified

FDA source

Recall record

Recall number: Z-0318-2027
Status: Open, Classified
Initiated: 2026-09-06
Posted: 2026-10-30
Recalling firm: Smith & Nephew, Inc.
Product: Evos 3.5Mm Lateral Proximal Tibia Plate 6 Hole Left 91Mm Ref72463106
Product code: HRS Plate, Fixation, Bone
Reason for recall: Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia Plate 6 hole left 91mm implant
FDA root cause: Labeling Change Control
Action: On September 3, 2026, Smith & Nephew, Inc. issued a Urgent Medical Device Recall Notice to affected consignees via 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. 1a. 0If you are a sales rep, district office, or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customer s account number and name in Section A. 2. If you have no product to return: a. Please put an X in the appropriate box below. b. Complete Section B of the form, sign and send to [email protected]. 3. If you have product to return: a. Please complete Section A - list the product part number, batches, and quantities that you are returning. b. Complete Section B of the form, sign and send to [email protected]. 4. Once the form is received by Smith+Nephew, you will be sent a Return Authorization (RA) number. 5. Return affected product to: Smith+Nephew | Attn: Quality Hold and Field Action Returns Department | 1450 E Brooks Road, Building G | Memphis, TN 38116
Quantity in commerce: 7 units
Distribution: US Nationwide distribution in the states of AZ, NV, TX, NM, WA, NY.
Product codes and lots: Lot: 25MM04429/UDI: 00885556640401

Product code HRS

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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 2026-10-28, the FDA export date for this dataset. Page last changed 2026-11-03. View this recall on fda.gov (opens on fda.gov)