GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6… recallZ-0447-2014 · Smith & Nephew Inc · initiated Aug 27, 2013
Class II Terminated All recalls posted in December 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
FDA root cause category: Package design/selection
What the company is doing
Smith & Nephew sent an Urgent Recall Notification letter dated August 27, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. They were instructed to cease use and distribution of the product and quarantine for return. Customers were instructed to contact Smith & Nephew via email at [email protected] or fax 901-566-7975 to obtain a return authorization (RA) number. Customers with questions were also instructed use this email address. Customers with affected product were instructed to return it along with the completed inventory Return Certification Form to the address listed on the form. Non-responding consignees were notified again on September 27, 2013, by email. For questions regarding this recall call 901-396-2121.
Recall details
- Recall number
- Z-0447-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 27, 2013
- Posted by the FDA
- Dec 4, 2013
- Recalling firm
- Smith & Nephew Inc
- Quantity
- 32 pieces
- Product code
- JWH
- FDA submissions
- K032295
- Distribution
- Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.
Product description
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Code information (models, lots, serial numbers)
Batch No. 12GT20904
Other devices under the same FDA submission
34 devices cleared under K032295 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- GENESIS II 71421508Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER52 reports
- GENESIS II 71421515Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER49 reports
- GENESIS II 71421516Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER35 reports
- GENESIS II 71421509Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER25 reports
- GENESIS II 71421522Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER23 reports
- GENESIS II 71421501Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- GENESIS II 71421510Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- GENESIS II 71421517Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- GENESIS II 71421524Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- ANTHEM 71422667Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- GENESIS II 71421502Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- GENESIS II 71421523Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 66333).
- Z-0444-2014 · TerminatedGENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
- Z-0445-2014 · TerminatedGENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
- Z-0446-2014 · TerminatedGENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
- Z-0448-2014 · TerminatedGENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
- Z-0449-2014 · TerminatedGENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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