Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M5725060
FDA device recall Z-2222-2012 · posted 2012-08-17 · Terminated
Recall details
- Recalling firm
- Conformis Inc
- Reason for recall
- Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique
- Action taken
- ConforMIS sent an Urgent Field Safety Notice letter dated July 5, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. An Addendum is included that provided updates to the Surgical Technique Guide. The updated technique guide will be delivered to all iTotal surgeons along with an on-site vist from ConforMIS sales representative. Customers were instructed to place the Surgical Technique Guide Addendum alongside the surgical plan, it puts the information in a highly visible location for the surgeon to review prior to the surgical procedure. Customers were asked to sign the communication verification form attached. For any questions regarding this notice, please contact your local ConforMIS representative or MDSS GmbH, Tel.: +49-511-62628630, info@mdss.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1427 units
- Distribution
- Worldwide Distribution - US Nationwide and the country of Germany
- Date initiated
- 2012-07-17
- Date posted
- 2012-08-17
- Date terminated
- 2013-02-27
- Location
- Burlington, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM (K103117) | Conformis, Inc. | 2011-01-07 |