Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods ac
FDA device recall Z-1023-2017 · posted 2017-01-13 · Terminated
Recall details
- Recalling firm
- Medacta Usa Inc
- Reason for recall
- Damaged packaging, lack of sterility assurance
- Action taken
- The firm, Medacta International, immediately notified all customers by phone on 12/07/16 and further notified via email on 12/9/16. The firm also issued an "URGENT- Field Safety Notice" dated 7/12/2016 to all its customers. The notice described the product, problem and actions to be taken. The customers were instructed to return all units to Medacta International SA and forward the notice to all people and organizations potentially affected. If you have any questions contact Regulatory Affairs Manager at +41 (0) 91 696 60 60.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 82 units
- Distribution
- Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland.
- Date initiated
- 2016-12-07
- Date posted
- 2017-01-13
- Date terminated
- 2017-11-15
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| M.U.S.T PEDICLE SCREW SYSTEM (K121115) | Medacta International | 2012-07-18 |