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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72407

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 08, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Synthes (USA) Products LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.

Z-0236-2016
Recall number
Z-0236-2016
Initiated
October 08, 2015
Classification
Class II
Status
Terminated
Quantity
20,494

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. In 1999, a module was released containing a small offering of the SNTRP plates. Synthes determined that the product in the SNTRP module is being used in spine surgeries, which are a contraindicated use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. In 1999, a module was released containing a small offering of the SNTRP plates. Synthes determined that the product in the SNTRP module is being used in spine surgeries, which are a contraindicated use.

Code information

Product Number Lot Number 489.401 4548779, 4545040, 4705188, 5106917 489.402 3949751 thru 6746734 A4FB851 thru A4JY300 489.403 3949753 thru 7097983 A4FB853 thru A4JV500 489.412 3950191 thru 6411381 A4FC274 thru A4JV496 489.413 3949756 thru 6819450 A4FB849 thru A4JR743 489.414 3929795 thru 6664281 A3JC152 thru A4JS596 489.415 3950185 thru 7464249 A4FB848 thru A4JS745 489.418 3949761 thru 7340734 A4FB855 thru A4JY299 489.423 3950186 thru 6714781 A4FC276 thru A4JJ712 489.424 3950189 thru 6714771 A4FB850 thru A4JV658 489.425 3173963 through 5836149 A4FC253 through A4JQ261

Distribution pattern

US Distribution to the states of :MO, NJ, MN, MS, AZ, CA, LA, OK, VA, OH, AR, FL, PA, VT, IN, AL, WA and NY.

Field note

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