Reported Sep 9, 2015 · Terminated
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR…
Synthes (USA) Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- 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.
- Lot codes and dates
- part numbers
497.087497.088497.089497.093497.094497.095497.098497.099497.100497.225497.226497.227497.228497.229497.230497.231497.232497.233497.234497.235497.236497.237497.238497.239497.241497.242497.243497.244497.245497.246497.247497.248497.249
- lot numbers
480 of 480 codes
455044349384814947780494778849555284955529495553258303335830334600531060118677371262737127574245957459468761302648144174884492493849549479694955498495550157703045830335601186873712637459469761302746862014814414493849749385014938766494797160118694362289439392348164224935344493851249385154938759494797757673595770641581209460118447371280742348076130444362288481642049385174938519493875849479786024576737128143622864816414
- part numbers
- Amount recalled
- 3262
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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