Z-1925-2014 Class II Terminated
FDA device recall Z-1925-2014 was initiated by Biomet, Inc. on May 15, 2014 and is designated Class II. Reason for recall: Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring… The recall status is terminated (terminated Mar 16, 2015). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 2, 2014
- Initiation Date
- May 15, 2014
- Termination Date
- Mar 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.
Reason for Recall
Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention.
Distribution Pattern
US Nationwide Distribution in the state of California
Code Information
Catalog/REF #: 114905, Lot #: M846640
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1925-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026