Recall Z-1911-2017
Smith & Nephew, Inc. · initiated March 30, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 14, REF 71369314, STERILE R, QTY: (1)
Codes / lots: Batch numbers: 431604,431612,431614,448956,469005,472361,472767,483297,483890,488786,496187,4500029102, 07LSY0037,07LSY0042,08ESY0005,08ESY0005A,08ESY0007,08ESY0008,08JSY0009,08JSY0009A, 08LSY0050,09BSY0019,09FSY0003,10CSY0007,10ESY0013,11GSY0006,11HSY0009,11KSY0003, 11KSY0069,11MSY0021,12FSY0002,12FSY0029,12GSY0007,12HSY0025,12HSY0040,12KSY0024, 12LSY0021,12MSY0005,12MSY0013,12MSY0025,13BSY0009,13BSY0016,13FSY0022,13JSY0022, 13KSY0048,13MSY0006,14CSY0006,14CSY0038,14HSY0006,15ASY0009,15ASY0018,15ASY0022, 15FSY0016,15JSY0006,15KSY0023,15KSY0039,15MSY0005,16ESY0059,16ESY0075,488369A
Reason for recall
The stability data does not support the product labeled with a 10-year shelf life.
FDA-determined cause: Error in labeling
Action taken
The firm initiated their recall by email and letter on 03/30/2017. Consignees were asked to inspect inventory to locate and quarantine affected product. All consignees are asked to complete a Response Form provided with the Field Safety Notice, regardless whether they have affected product. Affected inventory is then to be returned back to Smith & Nephew.
Details
- Recall number
- Z-1911-2017
- Initiated
- March 30, 2017
- Terminated
- August 21, 2019
- Product code
- KDG – Chisel (Osteotome)
- Quantity
- 1126 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
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1909-2017 Class II | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1910-2017 Class II | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1912-2017 Class II | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 16, REF 71369316, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1913-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1914-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369210, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1915-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 12 MM X 3 INCH, REF 71369212, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1916-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1917-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 5 INCH, REF 71369408, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1918-2017 Class II | RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1919-2017 Class II | RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |
| Z-1920-2017 Class II | RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)The stability data does not support the product labeled with a 10-year shelf life. | 03/30/2017Terminated |