VEPTR Vertical Expandable Prosthetic Titanium Rib — Class II medical device recall Z-2488-2015

Terminated recall by Synthes (USA) Products LLC, reported 2015-09-09, distributed nationwide. The last hole on certain VEPTR Inferior Cradles may be partially formed. Fully lengthening the construct to th

Recall number	`Z-2488-2015`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Synthes (USA) Products LLC, West Chester, PA, United States
Recall initiated	2015-07-29
Classified	2015-08-31
Reported by FDA	2015-09-09
Terminated	2016-08-18
Distributed	Nationwide (US)
Countries outside the US	CA, DE
Quantity	3,262
Reason classes	device malfunction
Lot numbers	`4208597`, `4208598`, `4208599`, `4362264`, `4362265`, `4362266`, `4362267`, `4362268`, `4362269`, `4362270`, `4362271`, `4362273`, `4362274`, `4362275`, `4362276`, `4362277`, `4362278`, `4362279`, `4362280`, `4362281`, `4362282`, `4362283`, `4362286`, `4362288`, `4362289`, `4393905`, `4393906`, `4393910`, `4393912`, `4393923`, `4393924`, `4550443`, `4550457`, `4550458`, `4550459`, `4550460`, `4550461`, `4562149`, `4568693`, `4568694` and 440 more
Model 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` and 8 more

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2488-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.