FDA Device recall Z-2488-2015
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports by Synthes Usa Products, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2488-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-29 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | part numbers: 497.087 497.088 497.089 497.093 497.094 497.095 497.098 497.099 497.100 497.225 497.226 497.22…part numbers: 497.087 497.088 497.089 497.093 497.094 497.095 497.098 497.099 497.100 497.225 497.226 497.227 497.228 497.229 497.230 497.231 497.232 497.233 497.234 497.235 497.236 497.237 497.238 497.239 497.241 497.242 497.243 497.244 497.245 497.246 497.247 497.248 497.249 lot numbers: 4550443 4938481 4947780 4947788 4955528 4955529 4955532 5830333 5830334 6005310 6011867 7371262 7371275 7424595 7459468 7613026 4814417 4884492 4938495 4947969 4955498 4955501 5770304 5830335 6011868 7371263 7459469 7613027 4686201 4814414 4938497 4938501 4938766 4947971 6011869 4362289 4393923 4816422 4935344 4938512 4938515 4938759 4947977 5767359 5770641 5812094 6011844 7371280 7423480 7613044 4362288 4816420 4938517 4938519 4938758 4947978 6024576 7371281 4362286 4816414 4816415 4938521 4938523 4938756 5811904 6011884 4362283 4562149 4617874 4816115 4816117 4884494 4938540 4947924 4947925 4 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2488-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.