Recall Z-0162-2016 ยท OSF Patient Specific Manual Orthopedic Stereotaxic System
Materialise N.V.
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
| Date | Oct 23, 2015 (initiated Sep 23, 2015) |
| Status | Terminated |
| Reason | Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed. |
| Root cause | Use error |
| Action | On September 16, 2015 Materialise NV identified four cases where not all available image sets were used to design the case. On September 18, 2015, prior to the surgery dates Materialise informed (phone call) the Signature Services Manager of Zimmer Biomet that inaccuracies in the alignment of the knee might be observed with the use of the guides due to this issue. Biomet was asked to segregate the packages for these four cases and to return them to the Materialise US office. On September 23, 2015 this was followed up by e-mail notification letter with response forms. Biomet was requested to co |
| Quantity | 4 |
| Distribution | Distributed in MI, ID, TX, and in France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102795 | SIGNATURE PLANNER; SIGNATURE GUIDES Materialise NV, Feb 2, 2011 |