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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 Systemsee related information
Date Initiated by FirmApril 14, 2011
Date PostedJune 08, 2011
Recall Status1 Terminated 3 on September 16, 2011
Recall NumberZ-2422-2011
Recall Event ID 58663
510(K)NumberK093235 
Product Classification Prosthesis, hip, semi-constrained (metal, uncemented acetabular component) - Product Code KWA
ProductRingloc + Acetabular Shell limited hole finned 48 mm Size 22 porous coat, for uncemented use, sterile, REF 16-104148, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) Ringloc Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflamnmatory 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 M105210, M181710, M211040, M582230, M618540, M618560 and M618570. 
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information ContactMary 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
ActionBiomet 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 Commerce49 units
DistributionWorldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KWA
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