Recall Z-2488-2015 ยท MDI Prosthesis, Rib Replacement
Synthes (USA) Products LLC
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
| Date | Aug 31, 2015 (initiated Jul 29, 2015) |
| Status | Terminated |
| Reason | The last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to rib sleeve breakage, and may require surgury to exchange components. Effects may also include pain, loss of deformity correction, and/or soft tissue/visceral injury. |
| Root cause | Process control |
| Action | Urgent recall letters, dated July 29, 2015, were sent to end users alerting them to the problem, the associated risk to patients, and provided instruction to return affected devices withthe response form. |
| Quantity | 3262 |
| Distribution | Worldwide distribution including US nationwide, Canada and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142587 | Vertical Expandable Prosthetic Titanium Rib Depuy Synthes Spine, Inc., Nov 18, 2014 |