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ATTUNE recallZ-1419-2022 · DePuy Orthopaedics, Inc. · initiated Jun 29, 2022

Open, Classified

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

Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain

FDA root cause category: Process control

What the company is doing

DePuy Synthes issued Urgent Medical Device Correction Letter on June 29 2022. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately for the subject lots and quarantine the products. 2. To minimize disruption, replacement of the spring will be completed by a Field Service Representative. You will be contacted directly by a member of the Field Service Team. 3. Familiarize yourself with the content of this letter and forward this notice to any personnel in your facility who need to be informed. 4. Complete all fields, sign, and return the attached business response form (BRF) on the last page of this letter to [email protected] within three (3) business days of receipt of this medical device correction letter. Please include FA 2126657 - Attune Measured Sizing & Rotation Guide in the email subject line. 5. Complete the BRF even if you do not have any of the subject product in your current inventory. 6. If any of the subject product has been forwarded to another facility, contact that facility, and provide a copy of this notice to the relevant personnel. 7. Post a copy of this notice in a visible area for awareness of this correction. Contact your local DePuy Synthes Sales Consultant. For Medical Information Requests, please visit our website: https://www.jnjmedicaldevices.com/mir

Recall details

Recall number
Z-1419-2022
Status
Open, Classified
Initiated by the company
Jun 29, 2022
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
872 units
Product code
HWT
Distribution
Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam

Product description

ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525

Code information (models, lots, serial numbers)

GTIN: 10603295434061  Lots: AB4536235, AB4733296,  AB4841493, AB4810808,  AB4841495, AB4904565,  AB4967214, AB5004557, and AB5034303

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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