—#127549

Product

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 product code: JDC — Prosthesis, Elbow, Constrained, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K013042
Affected lot / code info: Catalog/REF #: 114905, Lot #: M846640

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: US Nationwide Distribution in the state of California

Timeline

Recall initiated: 2014-05-15
Posted by FDA: 2014-06-26
Terminated: 2015-03-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127549. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.