Recall Z-1855-2017
Smith & Nephew, Inc. · initiated March 9, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
Codes / lots: Batch number 15KM05493
Reason for recall
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
FDA-determined cause: Labeling Change Control
Action taken
Smith & Nephew sent an Urgent Medical First Recall Notice dated March 9, 2017, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested the quarantine and return of the devices, and for the distributors to notify their consignees and ensure the same actions. International consignees were notified by email. Consignees with questions were instructed to contact FieldAction@smith-nephew.com. For questions regarding this recall call 978-749-1440.
Details
- Recall number
- Z-1855-2017
- Initiated
- March 9, 2017
- Terminated
- August 21, 2019
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 19 units
- Distribution
- Worldwide Distribution - US (Nationwide) Internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1854-2017 Class II | Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF…The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the… | 03/09/2017Terminated |
| Z-1856-2017 Class II | D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 OrthopedicThe expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the… | 03/09/2017Terminated |
| Z-1857-2017 Class II | D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X…The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the… | 03/09/2017Terminated |