Z-1252-2018Class II
Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI...
Stryker Corp. / initiated 2017-11-09 / Terminated / root cause: manufacturing process
Stryker Instruments Div. of Stryker Corporation began a recall of Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use on . FDA classified it as Class II and gives the reason as "Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1252-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Corp.
- Product
- Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000, UDI: (01)4546540912114 for orthopedic use.
- Product code
- JDZ Mixer, Cement, For Clinical Use
- Reason for recall
- Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
- Root cause tag
- manufacturing process
- FDA root cause
- Environmental control
- Action
- Letters dated November 16, 2017, were sent to customers. Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine if any devices from the affected lots are at your facility. 3. Quarantine and discontinue use of the recalled devices. 4. Complete and sign the enclosed Business Reply Form (BRF). 5. If you have further distributed these products, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF. 6. Return the completed BRF to Stryker Instruments Post Market Regulatory Compliance via fax (866-521- 2762) or email ([email protected]). 7. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. 8. Report any adverse events associated with the use of these devices to Stryker Instruments 1-800-253-3210, including any infections potentially associated with the use of affected product.
- Quantity in commerce
- 732
- 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.
- Product codes and lots
- Lot Number: 17290012 UDI: (01)4546540912114
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1243-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1244-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1245-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1246-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1247-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1248-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1249-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1250-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1251-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1252-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1253-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1254-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1255-2018 | Class II | Terminated | Voluntary: Firm initiated |
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