Legion(tm) Cocr Constrained Femoral Component recall
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Why was Legion(tm) Cocr Constrained Femoral Component recalled?
The stem taper on this device is undersized; the gauge point is not deep enough.
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?
Lot Numbers: 14EM16708, 14EM21988, 14DM22269
- Product
- LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 45 units
- Distribution
- Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.
- Recall date
- December 17, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)