Z-0200-2019Class II

Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION...

Name: Z-0200-2019 Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION...
Creator: Smith & Nephew, Inc.
Published: 2018-09-18
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2018-09-18 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical... on 2018-09-18. FDA classified it as Class II and gives the reason as "One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0200-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-18
Posted: 2018-10-22
Terminated: 2019-05-08
Recalling firm: Smith & Nephew, Inc.
Product: Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Smith & Nephew, notified their consignees with a notice entitled " Urgent Medical Device Recall Notice" by email on 09/18/2018. The notice The notice explained the problem and the potential hazard and requested return of the recalled units. The consignees are instructed to do the following: Please inspect your inventory and locate any devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately. a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainders of the form sign and send to [email protected] or fax to 901-566-7975. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact [email protected].
Quantity in commerce: 6 units
Distribution: US Distribution to the states of: KS and TN.
Product codes and lots: Lot 17LM05396

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0200-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0200-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-22

Product code MBH

K121393Class IISmith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc. / cleared 2012-08-07

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)