CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report
Revolution 90 Degree Tibial Nozzle, Product Number recalled
Stryker Instruments Div. of Stryker is recalling Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, distributed in District of Columbia. The recall was initiated on 9 Nov 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-1251-2018
- FDA event ID
- 79418
- Recalling firm
- Stryker Instruments Div. of Stryker, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2017
- FDA classified
- 28 Mar 2018
- Reported
- 4 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 9 Nov 2017 | Recall initiated by company | |
| 28 Mar 2018 | Classified by FDA | +139 days |
| 4 Apr 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
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
Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
Where it was distributed
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
Questions about this recall
Why was it recalled?
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Which lots are affected?
Lot Number: 17293012 UDI: (01)4546540911971
Where was it sold?
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
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
12 other products · FDA event 79418This product is part of a recall event; the main page for the event is Revolution CMS w/ Femoral Breakaway Nozzle & Med recalled.
More recalls from Stryker Instruments Div. of Stryker
All 161| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Triton Sponge System recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Device Malfunction | Nationwide |
| Device | CLASS II | Triton Canister System (finished part numbers FG recalled | Stryker Instruments Div. of Stryker | Device Malfunction | Nationwide |
| Device | CLASS II | SurgiCount+ System Application recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Device Malfunction | KS, ME |
| Device | CLASS II | Stryker Zyphr Disposable Cranial Perforator recalled | Stryker Instruments Div. of Stryker | Foreign Material | Nationwide |
| Device | CLASS II | Neptune E-sep Blade Electrode recalled by Stryker Instruments Div. of | Stryker Instruments Div. of Stryker | Other | MI |
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 |