Stryker Revolution CMS w/ Femoral Breakaway Nozzle: Risk of Contaminated Medical Devices
Stryker recalls Revolution CMS surgical devices with higher-than-acceptable bioburden levels. These devices may not be sterile, risking infections during orthopedic procedures. Affected units have specific product numbers and lot numbers.
Lower-risk recall
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Contact the company
What happened, in plain English
Stryker is recalling certain Revolution CMS surgical devices because they contain higher-than-acceptable levels of bacteria, which could lead to infections during orthopedic surgeries. This recall affects devices used in hospitals and clinics for specific surgical procedures. Read more at govinfonow.com/recall/72570-stryker-revolution-cms-w-femoral-breakaway-nozzle-risk-of-contaminated.
Source Summary by GovInfoNow · govinfonow.com/recall/72570-stryker-revolution-cms-w-femoral-breakaway-nozzle-risk-of-contaminated · Updated September 1, 2026 · FDA enforcement record: FDA #Z-1252-2018
Cite this page
“Stryker Revolution CMS w/ Femoral Breakaway Nozzle: Risk of Contaminated Medical Devices.” GovInfoNow, updated September 1, 2026. https://govinfonow.com/recall/72570-stryker-revolution-cms-w-femoral-breakaway-nozzle-risk-of-contaminated. Based on FDA recall #Z-1252-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1252-2018%22&limit=1).
Why it’s dangerous
The devices have higher-than-acceptable levels of bacteria (bioburden), which means they may not be sterile when used. This could lead to infections during surgical procedures if the devices are not properly sterilized.
Who’s affected
Healthcare professionals and hospitals using the recalled Revolution CMS devices for orthopedic procedures are most at risk. Patients undergoing surgery with these devices could face infection risks.
How to tell if you have this one
Check for the product number 0606-573-000 and lot number 17290012 on the device. The unique device identifier (UDI) is (01)4546540912114.
- Brand
Stryker- Category
Medical device
All 13 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
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1243-2018 | Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.; Lot Number: 17279012 UDI: (01)4546540039415 | 384 |
| Z-1244-2018 | 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.; Lot Numbers: 17277012, 17283012 UDI: (01)4546540857880 | 708 |
| Z-1245-2018 | 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.; Lot Number (Medium): 17276012; Lot Number (Large): 17282012 UDI: (01)4546540039552; (01)4546540039569 | 444 |
| Z-1246-2018 | 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.; 1. Lot Numbers: 17283012, 17284012, 17286012; 2. Lot Numbers: 17278012, 17280012, 17282012, 17283012, 17285012, 17289012, 17292012; 3. Lot Number: 17279012; 4. Lot Number: 17284012 UDI: (01)4546540861641; (01)4546540861764; (01)4546540861818; (01)4546540144300 | 5988 |
| Z-1247-2018 | 11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.; Lot Number: 17278012 UDI: (01)7613252594307 | 900 |
| Z-1248-2018 | Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.; Lot Numbers: 17282012, 17283012, 17297012, 17298012 UDI: (01)4546540055415 | 1542 |
| Z-1249-2018 | PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.; Lot Number: 17277012 UDI: (01)4546540907035 | 12 |
| Z-1250-2018 | 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.; 1. Lot Number: 17278012; 2. Lot Numbers: 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, 17291022 UDI: (01)4546540593108; (01)7613252039259 | 1244 |
| Z-1251-2018 | Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.; Lot Number: 17293012 UDI: (01)4546540911971 | 30 |
| Z-1252-2018 | Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.; Lot Number: 17290012 UDI: (01)4546540912114 | 732 |
| Z-1253-2018 | 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.; Lot Number: 17283012 UDI: (01)7613252029830 | 51 |
| Z-1254-2018 | 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.; 1. Shelf Life: 12 months; Lot Number: 17277012; 2. Shelf Life: 36 months; Lot Numbers: 17283012, 17299012 UDI: (01)7613252505983; (01)7613252505969 | 504 |
| Z-1255-2018 | Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.; Lot Number: 17284012 UDI: (01)4546540255853 | 320 |
What to do — step by step
Check Device Details
Look for the product number 0606-573-000 and lot number 17290012 on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury from this device?
The recall is due to potential infection risks from non-sterile devices, not direct injury risks like cuts or fires.
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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-1252-2018 (November 9, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1252-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 1, 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.