FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
- Recall number
- Z-0236-2016
- Recalling firm
- Synthes (USA) Products LLC
- Product
- Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
- Status
- Terminated
- Initiated
- 2015-10-08
- Posted
- 2015-11-06
- Terminated
- 2016-07-15
- Reason
- 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.
- Root cause
- No Marketing Application
- Action
- Synthes sent an Urgent Notice Medical Device Letter dated October 8, 2015. to all affected customer. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: "Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. "Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number, and signature in the spaces provided. "Return the Verification Form (page 3 of this letter) If you DO NOT have the identified product, please take the following steps: "Complete the attached Verification Section at the end of this letter by checking the appropriate box indicating that no affected product has been located. Please include your name, title, telephone number, and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. "Return the documents to Synthes by: "Fax: (866) 240-5364 or "Scan/email: Synthes4642@stericycle.com If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. Thank you for your attention to this issue.
- Quantity
- 20,494
- Distribution
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K915818"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3008812560
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28