—#194778

Product

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

FDA product code: HWT — Template
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: GTIN: 10603295434061 Lots: AB4536235, AB4733296, AB4841493, AB4810808, AB4841495, AB4904565, AB4967214, AB5004557, and AB5034303

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

Root cause (FDA determination)

Process control

Action the firm took

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 OneMD-Field-Actions@its.jnj.com 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

Recalling firm

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

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2022-06-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194778. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.