CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report
Reaming Rod, Ball tip, sterile recalled by Synthes (USA) Products
Synthes (USA) Products is recalling Reaming Rod, Ball tip, sterile, distributed nationwide in the US. The recall was initiated on 26 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0901-2018
- FDA event ID
- 79157
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jul 2017
- FDA classified
- 5 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 26 Jul 2017 | Recall initiated by company | |
| 5 Mar 2018 | Classified by FDA | +222 days |
| 14 Mar 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Which lots are affected?
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 2026-04-30
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 79157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Light Clip for Oracle Retractor, sterile recalled | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | Reaming Rod, Ball tip, sterile recalled by Synthes (USA) Products | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | Titanium Calibrated Reaming Rod recalled by Synthes (USA) Products | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | Reaming Rod, with straight ball tip, sterile recalled | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | Guide Rod, with smooth tip, sterile recalled by Synthes (USA) Products | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | Reaming Rod, Ball tip with extension, sterile recalled | Synthes (USA) Products | Sterility | Nationwide |
More recalls from Synthes (USA) Products
All 164| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 2.4 Volt(tm) Tap Cortex Screw recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| Device | CLASS II | 2.4 Volt Tap Locking Screw Tap recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Stardrive Scrwdrvr Shft/T4/Self-retaining/Hxc-Intended recalled | Synthes (USA) Products | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |