VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports
Medical device recall Z-2488-2015. Published in FDA’s Enforcement Report on Sep 9, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 9, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 3262 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
3262, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,995 characters
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 4955412 4955413 6005302 6011850 7371288 7844724 4362282 4685618 4698047 4816113 4938543 4938549 4947926 6011872 7371266 7423469 7544000 7613030 7775437 4362281 4393924 4685619 4816110 4938503 4938560 4947927 4947928 6011873 4362280 4393905 4550457 4568693 4617037 4686343 4686346 4694014 4694234 4755789 4755791 4755793 4821421 4882741 4882742 4882743 4882744 4947893 4947894 4947895 4947896 4947897 4947898 4947899 4947900 4969661 4969663 5816072 5857598 5883097 5883098 6031197 6031198 6079441 6087165 4362279 4393906 4550458 4568694 4617038 4686347 4686349 4686351 4694235 4709517 4755785 4755786 4755787 4821415 4882745 4882747 4882748 4938735 4947901 4947902 4947903 4947905 4947910 4969659 4969660 5642635 5702649 5744112 5744238 5883100 5883101 6011907 6024580 6087170 6087171 6087172 6087173 4362278 4393910 4550459 4617039 4686353 4694236 4709518 4755783 4755784 4821410 4882750 4882751 4882752 4882753 4938737 4947911 4947912 4947913 4969658 5668754 5697400 5770445 5857607 5872385 5883103 5883105 6021058 6024577 6031199 6031200 6063205 4362277 4550460 4568695 4617040 4686356 4694237 4755478…
FDA’s list runs to 4,130 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution including US nationwide, Canada and Germany.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 29, 2015.
- FDA classified it on Aug 31, 2015.
- FDA’s Enforcement Report published it on Sep 9, 2015.
- FDA terminated it on Aug 18, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Synthes (USA) Products LLC, of West Chester, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,130 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.