RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R, QTY: (1)
This recall has been terminated (originally issued March 30, 2017).
- Company
- Smith & Nephew Inc
- Recall Initiated
- March 30, 2017
- Terminated
- August 21, 2019
- Recall Number
- Z-1920-2017
- Quantity
- 742 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
The stability data does not support the product labeled with a 10-year shelf life.
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
Lot / Code Info
Batch numbers: 431604,431612,431614,467087,469005,472361,477931,481940,485498,488987,490565,491378, 492345,4500032273,07LSY0034,07LSY0041,07MSY0013,08FSY0052,08LSY0020,08LSY0020A, 08LSY0042,08MSY0020,09BSY0030,11DSY0007,11ESY0011,11FSY0006,11HSY0013, 11HSY0060,11JSY0008,11JSY0019,12KSY0027,12MSY0008,12MSY0016,13BSY0036, 13FSY0026,13KSY0016,14GSY0013,14KSY0005,15ASY0020,15ESY0015,15JSY0009,15MSY0009, 16ESY0079,477931A,477931B,477931C,490565A,492345A
Root 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.