—#162430

Product

(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

FDA product code: HRY — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K061648
Affected lot / code info: All lots

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: 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, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and the District of Columbia., and to the countries of : Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, India, Ireland, Italy, Korea, Luxembourg, Malaysia, Netherlands, Portugal, Singapore, Slovakia. Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.

Timeline

Recall initiated: 2017-12-21
Posted by FDA: 2018-03-20
Terminated: 2020-04-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162430. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.