Rotating Tibial Platform ATTUNE INTUITION Impactor. The recall
Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures.…
Why was Rotating Tibial Platform ATTUNE INTUITION Impactor. The recalled?
ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
CATALOG NO. : ATTUNE INTUITION Impactors Rotating Tibial Platform, (254401004) Barcode GTIN Number: Rotating Tibial Platform, ......... 10603295130208 ALL LOTS
- Product
- Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures.…
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 3861
- Distribution
- Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).
- Recall date
- January 14, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)