(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706

The SIGMA HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process.

Notifications were sent to the firm's consignees with the following instructions. Immediately Inspect Inventory: DISTRIBUTORS & SALES OFFICES: Inspect all inventory to identify any affected devices. 2. Return Affected U.S. Distributor/Sales Office Inventory: If any affected devices are found in a U.S. Distributors/Sales Offices inventory, return to: DePuy Synthes Joint Reconstruction 3. To Expedite the Return Process: Be sure to reference H17-19 on all return paperwork and/or online return forms and on the outside of the box when returning recalled devices. 4. Upon receipt of the affected devices, a credit will be issued using the normal returns process. 5. Identify Consignment Hospitals: Within 5-business days, complete the Distributor / Sales Office Response Card: 5.1. Provide the Medical Facility contact information and indicate the US Distributor/Sales Office has returned all affected devices. MEDICAL PROFESSIONALS: Steps to Take: " Cease using the affected components. " Return Affected Implants: Complete the reconciliation form and return to the sales consultant or fax to 574-371-4939 within five (5) days of this notice. Additional Notifications: o Notify surgeon users at your facility by providing them with a copy of this notice to ensure surgeon users are aware of this device recall. Forward this notice to others in your facility that need to be informed. o If any affected product has been forwarded to another facility, contact that facility immediately to communicate this field action with the facility/facilities. For further questions, please call (574) 372-7136.