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Lower risk Medical device recall · FDA · Published July 26, 2017

Synthes 2.5mm Reaming Rods Recall: Possible Sterility Risk

Synthes recalls 2.5mm reaming rods with potential sterility issues due to packaging seal gaps. These surgical tools were distributed from March 21 to June 23, 2017. Check product lot numbers for affected items.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0901-2018Medical deviceSynthes ›
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Recalling firmSynthes (USA) Products LLC1301 Goshen Pkwy · West Chester, PA 19380-5986
✎ GovInfoNow plain-language explainer

What happened, in plain English

Synthes is recalling 2.5mm reaming rods that may not be sterile because of gaps in the packaging seal. This could lead to infections during surgery if the rods are used without proper sterilization. Read more at govinfonow.com/recall/73347-synthes-2-5mm-reaming-rods-recall-possible-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/73347-synthes-2-5mm-reaming-rods-recall-possible-sterility-risk · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0901-2018

Cite this page

“Synthes 2.5mm Reaming Rods Recall: Possible Sterility Risk.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73347-synthes-2-5mm-reaming-rods-recall-possible-sterility-risk. Based on FDA recall #Z-0901-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0901-2018%22&limit=1).

Why it’s dangerous

The packaging seal may have gaps or channels that allow contaminants to enter the sterile rod packaging. This could lead to infections if the rods are used in surgery without being properly sterilized.

Who’s affected

Orthopedic surgeons and medical professionals who used these reaming rods during surgery between March 21 and June 23, 2017. Patients who received these rods for procedures are at risk of infection if the rods were not properly sterilized.

How to tell if you have this one

Check for the part number 351.706S on the packaging. These rods were distributed from March 21 to June 23, 2017, with specific lot numbers listed in the recall notice.

  • Brand
    Synthes
  • Category
    Medical device
FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.
Recall numberProduct, codes & lotsQuantity
Z-0901-20182.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.; Distributed 21-Mar-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H229232 2/14/2017 2026-01-31 H239057 4/9/2017 2026-02-28 H333939 4/9/2017 2026-02-28 H333940 4/9/2017 2026-02-28 H294380 4/16/2017 2026-03-31 H294383 4/16/2017 2026-03-31 H339342 4/18/2017 2026-03-31 H339343 4/18/2017 2026-03-31 H339349 4/18/2017 2026-03-31 H340100 4/18/2017 2026-03-31 H340112 4/18/2017 2026-03-31 H340114 4/18/2017 2026-03-31 H294387 4/19/2017 2026-03-31 H294393 4/19/2017 2026-03-31 H341135 4/19/2017 2026-03-31 H342141 4/19/2017 2026-03-31 H294373 4/21/2017 2026-03-31 H340383 4/21/2017 2026-03-31 H340912 4/21/2017 2026-03-31 H341208 4/21/2017 2026-03-31 H342137 4/21/2017 2026-03-31 H341210 4/22/2017 2026-03-31 H343361 4/22/2017 2026-03-31 H343364 4/22/2017 2026-03-31 H343365 4/22/2017 2026-03-31 H297302 4/25/2017 2026-03-31 H340913 4/25/2017 2026-03-31 H341207 4/25/2017 2026-03-31 H341213 4/25/2017 2026-03-31 H342135 4/25/2017 2026-03-31 H342142 4/25/2017 2026-03-31 H297313 4/28/2017 2026-03-31 H297328 4/28/2017 2026-03-31 H341209 4/28/2017 2026-03-31 H341212 4/28/2017 2026-03-31 H342136 4/28/2017 2026-03-31 H342140 4/28/2017 2026-03-31 H297312 5/3/2017 2026-03-31 H297324 5/3/2017 2026-03-31 H297330 5/3/2017 2026-03-31 H297336 5/3/2017 2026-03-31 H297333 5/4/2017 2026-03-31 H297337 5/4/2017 2026-03-31 H297350 5/4/2017 2026-03-31 H297358 5/4/2017 2026-03-31 H340918 5/4/2017 2026-03-31 H341132 5/4/2017 2026-03-31 H297329 5/6/2017 2026-03-31 H297360 5/6/2017 2026-03-31 H297366 5/6/2017 2026-03-31 H297356 5/10/2017 2026-03-31 H297359 5/10/2017 2026-03-31 H297362 5/10/2017 2026-03-31 H297374 5/10/2017 2026-03-31 H294394 5/11/2017 2026-04-30 H294401 5/11/2017 2026-04-30 H297319 5/11/2017 2026-04-30 H297340 5/11/2017 2026-04-30 H297383 5/11/2017 2026-04-30 H325599 5/11/2017 2026-04-30 H340394 5/11/2017 2026-04-30 H294404 5/12/2017 2026-04-30 H294407 5/12/2017 2026-04-30 H297307 5/12/2017 2026-04-30 H297308 5/12/2017 2026-04-30 H297310 5/12/2017 2026-04-30 H297334 5/12/2017 2026-04-30 H297343 5/12/2017 2026-04-30 H297370 5/12/2017 2026-04-30 H297377 5/12/2017 2026-04-30 H297380 5/12/2017 2026-04-30 H297385 5/12/2017 2026-04-30 H335085 5/12/2017 2026-04-30 H294391 5/18/2017 2026-04-30 H297309 5/18/2017 2026-04-30 H335089 5/18/2017 2026-04-30 H342583 5/18/2017 2026-04-30 H297315 5/23/2017 2026-04-30 H297367 5/23/2017 2026-04-30 H297386 5/23/2017 2026-04-30 H325607 5/23/2017 2026-04-30 H325615 5/23/2017 2026-04-30 H294402 5/24/2017 2026-04-30 H297335 5/24/2017 2026-04-30 H325600 5/24/2017 2026-04-306257
Z-0902-20182.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.; Distributed 17-Apr-2017 to 8-June-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H040501 7/29/2016 2025-06-30 H105498 8/5/2016 2026-02-28 H213824 10/27/2016 2025-09-30216
Z-0903-20182.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.; Distributed 10-Mar-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H311894 3/9/2017 2026-01-31 H311912 3/9/2017 2026-01-31 H311913 3/9/2017 2026-01-31 H311941 3/9/2017 2026-01-31 H311942 3/9/2017 2026-01-31 H311925 3/14/2017 2026-01-31 H311938 3/14/2017 2026-01-31 H311924 4/9/2017 2026-01-31 H334430 4/13/2017 2026-02-28 H334555 4/13/2017 2026-02-28 H334556 4/19/2017 2026-02-28 H336080 4/19/2017 2026-03-31 H336081 4/19/2017 2026-03-31 H336083 4/19/2017 2026-03-31 H317169 5/10/2017 2026-03-31 H317170 5/10/2017 2026-03-311144
Z-0904-20183.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.; Distributed 25-Apr-2017 to 22-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H306632 4/3/2017 2026-02-28 H311229 4/16/2017 2026-03-31 H311228 4/28/2017 2026-03-31 H311231 4/28/2017 2026-03-31 H319172 4/28/2017 2026-03-31 H319175 4/28/2017 2026-03-31 H318789 5/4/2017 2026-03-31 H319171 5/4/2017 2026-03-31 H327068 5/4/2017 2026-03-31 H311226 5/6/2017 2026-03-31 H311225 5/11/2017 2026-04-30 H311224 5/12/2017 2026-04-30 H327067 5/12/2017 2026-04-30 H327066 5/18/2017 2026-04-30960
Z-0905-20182.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.; Distributed 31-May-217 to 20-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H354470 5/27/2017 2026-04-3021
Z-0906-20182.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.; Distributed 12-May-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H270855 5/12/2017 2026-04-3063
Z-0907-2018Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.; Distributed 21-Apr-2017 to 12-May-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H310383 4/20/2017 2022-02-28 H322619 4/20/2017 2022-02-28 H327938 4/20/2017 2022-02-286
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the part number 351.706S on the packaging to confirm if the item is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

1. Firm started the recall: Jul 26, 201712. FDA classified it Class II: Mar 5, 201823. Published in FDA’s Enforcement Report: Mar 14, 201834. FDA terminated the recall: Sep 10, 2018420172018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0901-2018 (July 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0901-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA