REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis, knee) SET 04-05 DGHUMPHR-NOV52LKA-J_K-00432022 SLIDEX DISTAL-MP/
FDA device recall Z-1145-2012 · posted 2012-03-02 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- 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.
- Action taken
- 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 personnel of this action, via the enclosed recall letter. This letter MUST be given to hospital personnel responsible for receiving recall notices. Confirm receipt of this notice by calling, 800-348-9500, extension 3983. Questions related to this notice should be directed to 574-372-3983, Monday through Friday, 8AM to 5PM.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 2 units
- Distribution
- Nationwide distribution:Virginia and Ohio only.
- Date initiated
- 2011-08-04
- Date posted
- 2012-03-02
- Date terminated
- 2012-09-06
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIGNATURE PLANNER; SIGNATURE GUIDES (K102795) | Materialise NV | 2011-02-02 |