LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 714
FDA device recall Z-2625-2017 · posted 2017-06-12 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- The incorrect Loctite adhesive was used to assemble the impactor heads.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 46 units
- Distribution
- US distribution to TN
- Date initiated
- 2017-05-30
- Date posted
- 2017-06-12
- Date terminated
- 2021-12-10
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Legion Cone System (K162775) | Smith & Nephew, Inc. | 2017-01-13 |