Recall Z-1145-2012 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Biomet, Inc.
REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis, knee) SET 04-05 DGHUMPHR-NOV52LKA-J_K-00432022 SLIDEX DISTAL-MP/PREMIER TIBIAL CUSTOM-MADE DEVICE Signature Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in the guiding and marking of bone before cutting and
| Date | Mar 2, 2012 (initiated Aug 4, 2011) |
| Status | Terminated |
| Reason | Biomet has initiated this action following investigation that identified two (2) specific lots of part number 42-422561 were incorrectly labeled. One (1) unit (lot 025640) was received back from distributor's office as a product complaint. |
| Root cause | Labeling mix-ups |
| Action | The firm, BIOMET Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated January 23, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: -Immediately locate and remove the above identified Signature " Guide and Model Set. -Carefully follow the instructions on the enclosed FAX Back Response Form. - Fax a copy of the Response Form to 574-372-1683 prior to return of product. - Use priority carrier for your shipment. - If you have further distributed this product, you MUST notify hospital pers |
| Quantity | 2 units |
| Distribution | Nationwide distribution:Virginia and Ohio only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102795 | SIGNATURE PLANNER; SIGNATURE GUIDES Materialise NV, Feb 2, 2011 |