VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR I
FDA device recall Z-2488-2015 · posted 2015-08-31 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MDI
- Quantity affected
- 3262
- Distribution
- Worldwide distribution including US nationwide, Canada and Germany.
- Date initiated
- 2015-07-29
- Date posted
- 2015-08-31
- Date terminated
- 2016-08-18
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Vertical Expandable Prosthetic Titanium Rib (K142587) | Depuy Synthes Spine, Inc. | 2014-11-18 |