—#99896

Product

Ringloc + Acetabular Shell limited hole, 58 mm Size 25, porous coat, for uncemented use, sterile, REF 16-116058, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.

FDA product code: KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device class: Class 3
Medical specialty: Orthopedic
510(k) numbers: K093235
Affected lot / code info: Lot numbers M510790, M510800, M799990, M903250 and M089400.

Why it was recalled

The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in the acetabular shell, the liner cannot be completely seated in the shell.

Root cause (FDA determination)

Employee error

Action the firm took

Biomet Orthopedics sent an URGENT MEDICAL DEVICE RECALL NOTICE DATED April 14, 2011, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Immediately locate and remove the affected product. Follow the instructions on the enclosed "FAX Back Response Form" and fax a copy of the Response Form to 574-372-1683 prior to return of product. Customers were to confirm receipt of the notice by calling 800-348-9500, ext 3755 or 3756. For any questions regarding this recall call 574-371-3755 or 574-371-3756.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.

Timeline

Recall initiated: 2011-04-14
Posted by FDA: 2011-06-08
Terminated: 2011-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99896. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.