Recall Z-0069-2017 ยท LXH Orthopedic Manual Surgical Instrument
Cardinal Health 200, LLC
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
| Date | Sep 23, 2016 |
| Status | Terminated |
| Reason | Potential risk associated with corrosion demonstrated on the distraction screw surface. |
| Root cause | Package design/selection |
| Action | On September 23, 2016, Becton Dickinson sent a Field Safety Notice to all affected customers describing the details of the recall and necessary action to take. ACTIONS TO BE TAKEN BY BD: A credit will be applied to your account for the affected product upon receipt of the affected unit(s) or receipt of certification of destruction documented on the customer response form. Complete the Recall Response form certifying that all affected product in your inventory has been destroyed and mail/email a copy of the response form.: The firm requests customers to promptly return the enclosed res |
| Quantity | 72,076 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Germany, New Zealand, Saudi Arabia, South Africa, Switzerland and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.