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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 Device Recall Porous Plasma Spray (PPS) Ringloc Acetabular System see related information
Date Initiated by Firm April 14, 2011
Date Posted June 08, 2011
Recall Status1 Terminated 3 on September 16, 2011
Recall Number Z-2431-2011
Recall Event ID 58663
510(K)Number K093235  
Product Classification Prosthesis, hip, semi-constrained (metal, uncemented acetabular component) - Product Code KWA
Product Ringloc + Acetabular Shell limited hole finned 66 mm Size 27 porous coat, for uncemented use, sterile, REF 16-104166, 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 M565200 and M704090. 
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
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		 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 16
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWA and Original Applicant = BIOMET, INC.
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