Renovation recall
RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)
Why was Renovation recalled?
The stability data does not support the product labeled with a 10-year shelf life.
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?
Batch numbers: 07MSY0001,08CSY0035,08FSY0034,08FSY0035,08FSY0035A,08LSY0013,08MSY0017,09BSY0023, 09BSY0026,09BSY0026A,09DSY0008,09FSY0006,09HSY0003,09HSY0007,09JSY0003,10CSY0004, 10CSY0015,10CSY0016,10DSY0002,10ESY0009,10ESY0015,10ESY0019,11CSY0009,11CSY0015, 11FSY0007,11GSY0003,11GSY0022,11GSY0023,11HSY0062,11JSY0003,11MSY0018,12ASY0010, 12BSY0012,12CSY0005,12DSY0022,12DSY0028,12FSY0027,12HSY0007,12HSY0036,12KSY0016, 12KSY0022,12LSY0018,12LSY0023,12MSY0012,13ASY0007,13BSY0040,13DSY0009,13DSY0017, 13ESY0008,13ESY0009,13HSY0004,14ASY0034,14CSY0005,14CSY0034,14DSY0016,14DSY0018, 14GSY0016,14KSY0030,14LSY0010,14MSY0012,15ASY0023,15DSY0005,15ESY0020,15FSY0019, 15HSY0011,15JSY0045,15KSY0022,15LSY0070,16ASY0002,16BSY0009,16DSY0022,16ESY0058, 16ESY0077,16JSY0006,3000084920,431604,4500025459,4500030972,4500032273,4500032565, 4500034104,452406,456888,472579,483297,485498
- Product
- RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 4947 units
- Distribution
- Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela
- Recall date
- May 10, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)