LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
This recall has been terminated (originally issued June 12, 2017).
- Company
- Smith & Nephew Inc
- Recall Initiated
- May 30, 2017
- Posted
- June 12, 2017
- Terminated
- December 10, 2021
- Recall Number
- Z-2624-2017
- Quantity
- 36 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
The incorrect Loctite adhesive was used to assemble the impactor heads.
Distribution
US distribution to TN
Lot / Code Info
Lot numbers: a) 16HGA0031 b) 16HGA0034 c) 16HGA0035
Root Cause
Process control
Action Taken
The firm notified the consignee by email on 05/30/2017. The notice directed the consignee to inspect its inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. Distributors were directed to notify their customers of the field action and ensure the recall directions were followed.
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