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1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog… recallZ-1219-2018 · DePuy Orthopaedics, Inc. · initiated Dec 21, 2017

Class II Terminated All recalls posted in March 2018

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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 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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1219-2018
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 21, 2017
Posted by the FDA
Mar 20, 2018
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
2110
Product code
HRY
FDA submissions
K061648
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, 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.

Product description

(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

Code information (models, lots, serial numbers)

All lots

Other devices under the same FDA submission

8 devices cleared under K061648 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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