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U.S. Department of Health and Human Services

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 Class 2 Recall
Porous Plasma Spray (PPS) Ringloc ® Acetabular System		see related information
Date Posted June 08, 2011
Recall Number Z-2422-2011
Product Ringloc + 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, Indiana 46582
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mary Johnson
574-267-6639 Ext. 1676
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.
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 49 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
 
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