ATTUNE Measured Sizing and Rotation Guide-to recall
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…
Why was ATTUNE Measured Sizing and Rotation Guide-to 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 10603295434061 Lots: AB4536235, AB4733296, AB4841493, AB4810808, AB4841495, AB4904565, AB4967214, AB5004557, and AB5034303
- 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…
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 872 units
- 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
- Recall date
- July 27, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)