Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) N
FDA device recall Z-0442-2013 · posted 2012-11-27 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
- Action taken
- The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 8, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to take the following actions: Immediately locate and remove the identified device(s) listed below from circulation. 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. Questions related to notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- KWA
- Quantity affected
- 4
- Distribution
- Nationwide distribution: USA including states of: AZ, MD, and KS.
- Date initiated
- 2012-11-06
- Date posted
- 2012-11-27
- Date terminated
- 2013-08-28
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ECHO BI-METRIC PRESS-FIT STEMS (K070274) | Biomet Manufacturing Corp | 2007-04-03 |