Z-0573-2016Class II

Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED...

Name: Z-0573-2016 Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED...
Creator: Smith & Nephew, Inc.
Published: 2015-11-09
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2015-11-09 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF... on 2015-11-09. FDA classified it as Class II and gives the reason as "One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation". 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-0573-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-09
Posted: 2016-01-04
Terminated: 2016-03-17
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm, Smith & Nephew Inc, notified the distributors by Fed- Ex on 10/20/2015 and sent an "Urgent - Product Recall 1st Notification - Urgent R-2015-22" letter dated 11/9/2015 to their customers. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect your inventory and locate any unused devices, quarantine them immediately, complete and return the Inventory Return Certification Form by fax to: +1-901-566-7975 or email to: [email protected], even if you do not have the product, contact Smith & Nephew's Field Actions Department via email or fax (above) to obtain a return authorization (RA) number, and return any affected product to Smith & Nephew, Attn: Global Field Actions, Global Distribution Center, 3303 E Holmes Road, Memphis, TN 38118. If you have any questions, call Director, Regulatory Affairs 901-399-5520 or email: [email protected].
Quantity in commerce: 20 units
Distribution: US Distribution to states of:FL, MO, IN and TX.
Product codes and lots: Batch # 15GM07831

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0573-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0573-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-04

Product code JWH

K951987Class IIGenesis II Total Knee SystemSmith & Nephew Richards, Inc. / cleared 1995-08-22

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)