EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106
Smith & Nephew, Inc. · 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…
Open FDA's page for this record- Cfres ID
- 222849
- Product res number
- Z-0318-2027
- Event date initiated
- 2026-09-06
- Event date posted
- 2026-10-30
- Recall status
- Open, Classified
- Res event number
- 99904
- Product code
- HRS
- Product description
- EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106
- Code info
- Lot: 25MM04429/UDI: 00885556640401
- Firm FEI number
- 1020279
- Recalling firm
- Smith & Nephew, Inc.
- Address 1
- 1450 E Brooks Rd
- City
- Memphis
- State
- TN
- Postal code
- 38116-1804
- Additional info contact
- David Snyder 901-396-2121
- Root cause description
- Labeling Change Control
- Product quantity
- 7 units
- Distribution pattern
- US Nationwide distribution in the states of AZ, NV, TX, NM, WA, NY.
- 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
- 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 FieldActions@smith-nephew.com. 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 FieldActions@smith-nephew.com. 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
- K numbers
- K170457, K210837, K213126
- Harmonized identifiers (openFDA)
- Device name
- Plate, Fixation, Bone
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3030
- Device class
- 2
- K number
- K152289, K243357, K181091, K213712, K063875, K250865, K094037, K251050, K081407, K100944, K133691, K063506, K132642, K223933, K261647, K232144, K980368, K910482, K090692, K231292, K131834, K223342, K143523, K972223, K152253, K172425, K993106, K202803, K153482, K101421, K040112, K800806, K913271, K212297, K191793, K220463, K061012, K161303, K113718, K131311 +1,294 more
- Registration number
- 3008534770, 3009196021, 3008951116, 3010362364, 3009923578, 3031261833, 3010118938, 3008747271, 3015410662, 3009971621, 3011500362, 9611274, 3010009693, 9615766, 8031010, 3030714745, 9680825, 3009532798, 1450662, 3009540749, 3015212339, 3008650117, 3012478585, 9610612, 2133928, 8031020, 3024813436, 3038503572, 3004513872, 1224360, 3007125392, 3013086329, 3004941535, 3015869121, 3006498370, 3030412764, 3010863450, 3019807891, 3010123256, 3015075784 +481 more
- FEI number
- 3002807036, 3002807038, 3008534770, 3003056094, 3009196021, 3008951116, 3010362364, 1000115331, 3009923578, 3031261833, 3007282753, 3010118938, 3001814066, 3008747271, 1000306431, 3015410662, 3009971621, 3008647423, 3004574120, 3011500362, 3010009693, 3030714745, 3009532798, 1000221916, 1450662, 3009540749, 3015212339, 3008650117, 3012478585, 3002287318, 3024813436, 3038503572, 3004513872, 3010938185, 3007125392, 3013086329, 3000717902, 3004941535, 3015869121, 3006498370 +481 more