(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemente

FDA device recall Z-1219-2018 · posted 2018-03-20 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

HRY

Quantity affected

2110

Distribution

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS,

Date initiated

2017-12-21

Date posted

2018-03-20

Date terminated

2020-04-01

Location

Warsaw, IN

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