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U.S. Department of Health and Human Services

Class 2 Device Recall Porous Plasma Spray (PPS) Ringloc Acetabular System

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 Class 2 Recall
Porous Plasma Spray (PPS) Ringloc Acetabular System
see related information
Date Posted June 08, 2011
Recall Status1 Terminated on September 16, 2011
Recall Number Z-2438-2011
Recall Event ID 58663
Premarket Notification
510(K) Number
K093235 
Product Classification Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) - Product Code KWA
Product Ringloc + Acetabular Shell limited hole, 56 mm Size 24, porous coat, for uncemented use, sterile, REF 16-116056, 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.
Code Information Lot numbers M010360, M144400, M160860, M510780, M592160 and M592170.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mary Johnson
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
TRAINING: Employee Error
Action 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.
Quantity in Commerce 48
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWA and Original Applicant = BIOMET, INC.
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