RENOVATION, THIN OSTEOTOME BLADE, 10 MM X 3 INCH, REF 71369410, STERILE R, QTY: (1)
Enforcement
- Recall Number
- Z-1918-2017
- Event ID
- 76943
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Smith & Nephew, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 10, 2017
- Initiation Date
- March 30, 2017
- Classification Date
- May 2, 2017
- Termination Date
- August 21, 2019
- Address
- 1450 E Brooks Rd, Memphis, TN, 38116-1804, United States
Description
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.
Batch numbers: 452406,455856,456888,467087,469005,477931,483890,485094,485498,492100,492345,4500028121, 4500029102,4500032565,07MSY0025,08CSY0040,08FSY0036,08JSY0001,08JSY0010,08JSY0010A, 08JSY0031,08JSY0031A,08KSY0009,08LSY0005,08LSY0021,08LSY0022,08MSY0004,09BSY0028, 09HSY0009,10CSY0010,10CSY0021,10CSY0022,10ESY0010,10ESY0018,10KSY0034,11CSY0010, 11DSY0005,11DSY0013,11DSY0050,11ESY0009,11FSY0005,11GSY0008,11GSY0027,11HSY0011, 11HSY0059,11JSY0005,12ASY0015,12BSY0016,12DSY0017,12ESY0002,12FSY0004,12GSY0031, 12HSY0027,12HSY0043,12KSY0026,12MSY0006,12MSY0028,13BSY0017,13BSY0034,13ESY0007, 13FSY0025,13JSY0023,13KSY0012,13LSY0012,14BSY0001,14BSY0025,14CSY0041,14GSY0020, 14HSY0013,14KSY0004,14KSY0032,14LSY0016,15ASY0017,15ASY0019,15ASY0024,15CSY0008, 15DSY0003,15ESY0013,15FSY0021,15HSY0006,15JSY0010,15KSY0038,15MSY0007,16ASY0008, 16BSY0015,16ESY0080,496187A
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
4033 units