REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis… recallZ-1145-2012 · Biomet, Inc. · initiated Aug 4, 2011
Terminated All recalls posted in March 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-1145-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 4, 2011
- Posted by the FDA
- Mar 2, 2012
- Recalling firm
- Biomet, Inc.
- Quantity
- 2 units
- Product code
- JWH
- FDA submissions
- K102795
- Distribution
- Nationwide distribution:Virginia and Ohio only.
Product description
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 to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Code information (models, lots, serial numbers)
Catalog number 42-422561 Lot numbers: 025565 & 025640
Other devices under the same FDA submission
1 device cleared under K102795 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Signature 42-422551Materialise NV · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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