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.
FDA Recall Z-1925-2014 · Posted 2014-06-26
Advertisement
Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJDC
Date Initiated2014-05-15
Date Terminated2015-03-16
Product Quantity1
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.
Firm Action
Biomet sent an Urgent Medical Device Recall Notice letter dated May 28, 2014 to their customer. The letter identified the affected product, problem and actions to be taken. The letter instructed physician to monitor the patient for any pain that may require surgical intervention. For questions call (574) 372-1570.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide Distribution in the state of California
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement