OCTOBER 2000

WEEK ENDING OCTOBER 6

PRODUCT Centrex Bipolar Endoprothesis Comp, used in comjunction with a femoral stem component in the reconstruction of a femoral head damaged by fresh fracture non-union aseptic necrosis of the femoral head and neck or by osteoarthritis or post-traumatic arthritis.
CODE Catalog No. 6225-2-846, Lot Code GOUDA.
MANUFACTURER Howmedica Osteonics Corporation, Rutherford, New Jersey.
DISTRIBUTION Nationwide, Australia and Canada.
QUANTITY 11 units were distributed.
REASON A 26mm UHWPE insert was issued instead of a 28mm insert.

PRODUCT Titanium Roof Pile Screw, Catalog #1001-05-501, intended for use to fixate Depuy Protrusio Rings.
CODE Lot TE7GR1.
MANUFACTURER DePuy Orthopaedics, Inc., Warsaw, Indiana.
DISTRIBUTION Nationwide and Canada.
QUANTITY 20 pieces were distributed.
REASON The device was incorrectly labeled as sterile when it was not properly sterilized.

PRODUCT Power Chairs: a) Rascal Model Numbers RAS 545 and RAS 445;b) Chauffeur Model Numbers: P48, S45, X48, and X48E.
CODE Identified power chairs are: PC004492, PC004493, PC004494, PC004501, PC004502, PC004508, PC004511, PC004527, PC004532, PC004534, PC004536, PC004552, PC004553, PC004555, PC004556, PC004579, JS004709.
MANUFACTURER Electric Mobility Corporation, Sewell, New Jersey.
DISTRIBUTION a) North Carolina, Indiana, Florida, Pennsylvania, New York, Kentucky, California, Kansas, Mississippi, and West Virginia, England; b) Alabama.
QUANTITY 17 chairs were distributed.
REASON The Power chairs' controller program does not meet the original engineering specifications.

PRODUCT Isoniazid drug lot No. 9335260 used in the following kits: BACTEC(tm) S.I.R.E. Drug Kit used for susceptibility testing of Mycobacterium tuberculosis, Catalog No. 442102, Lot Nos. 9327296, 93442298, 9327298; BACTEC(tm) Isoniazid Drug Kit used for isoniazid susceptibility testing, Catalog No. 442146, Lot No. 9327297.
CODE See above.
MANUFACTURER Becton Dickinson Microbiology Systems, Cockeysville, Maryland.
RECALLED BY Becton Dickinson Microbiology Systems, Sparks, Maryland
DISTRIBUTION Nationwide, Hong Kong, Philippines, Australia, Brazil, New Delhi, Singapore, Puerto Rico, Belgium, Canada, Argentina.
QUANTITY 148 Isoniazid Drug Kits and 490 S.I.R.E. Kits were distributed.
REASON Some bottles of the products listed above are labeled Isoniazid but actually contain Streptomycin.

PRODUCT Vitros Immunodiagnostic Products brand of: Prolactin Reagent Pack, 100 test units per pack Catalog No.184 9793; and associated Vitros Prolactin Calibrators, Catalog No. 111 3596, for in vitro diagnostic use only.
CODE
Catalog No. 1849793, Lot No.90, EXP 09/15/2000;
Catalog No. 1112595, Lot No.90, EXP 09/15/2000.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Forest Farm Estate Whitchurch, Cardiff, UK.
RECALLED BY Ortho-Clinical Diagnostics, Inc., Rochester, New York
DISTRIBUTION Alabama, Arizona, Kansas, Missouri, Virginia, Washington state, Argentina, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Puerto Rico, Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.
QUANTITY 764 packs were distributed.
REASON Calibration failures may occur when using this lot of product due to lower than expected light unit output for the level 1 calibrator.

PRODUCT Replace 4.3mm Conical Abutment, 4.3mm diameter x 4.5 mm height, Catalog #43503. An abutment is used either for single or multiple unit, screw-retained prosthetic restorations.
CODE Lot #308039 EXP 2/05.
MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California.
DISTRIBUTION Florida, Illinois, Louisiana, Michigan, Minnesota, North Carolina, New York, Ohio, Pennsylvania, Texas, Hong Kong, Israel, Mexico.
QUANTITY 40 units were distributed.
REASON The conical abutment was not the size as labeled.

PRODUCT IMC (Intramobile Connector) Conversion Screw, 3.3mm diameter, Catalog #8198CA. An IMC cylinder is used for either single or multiple unit, screw-retained prosthetic restorations.
CODE Lot #310052.
MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California.
DISTRIBUTION Arizona, Connecticut, Delaware, Florida, Indiana, Massachusetts, Maryland, Michigan, New Jersey, New York, Ohio, Texas.
QUANTITY 29 units were distributed.
REASON The screw in the package is incorrect.

PRODUCT Gold Cylinder Fastening Screw, 3.3mm diameter x 12 mm height. Catalog #8905A. an IMC cylinder is used either for single or multiple unit, screw-retained prosthetic restorations.
CODE Lot #309634.
MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California.
DISTRIBUTION New Jersey.
QUANTITY 6 units were distributed. All units have been returned.
REASON The screw in the package is incorrect.

PRODUCT Replace 4.3mm Conical Abutment, 4.3mm diameter x 1.5mm height, Catalog #43500. An abutment is used either for single or multiple unit, screw-retained prosthetic restorations.
CODE Lot #308028 EXP 2/05.
MANUFACTURER Nobel Biocare USA, Inc., Yorba Linda, California.
DISTRIBUTION California, Florida, Idaho, Indiana, New York, Colombia, Hong Kong, Mexico, South Korea.
QUANTITY 41 units were distributed.
REASON The conical abutment was not the size as labeled.

PRODUCT ProCide-D Plus Sterilizing & Disinfecting Solution.
CODE Lot #200020002 EXP 7/02
MANUFACTURER Metrex Research Corporation, Parker, Colorado.
RECALLED BY Sybron Dental Specialties, Inc., Orange, California
DISTRIBUTION Alabama, Iowa, Indiana, New York, Oregon, Pennsylvania, West Virginia, Texas.
QUANTITY 280 gallons were distributed.
REASON Part of the subject lot was mislabeled as Procide-D Plus, which contains 3.4% glutaraldehyde, rather Procide-D, which contains 2.5% glutaraldehyde.

WEEK ENDING OCTOBER 13

PRODUCT Datex-Ohmeda AS/3 Anesthesia Delivery Unit (ADU), a complete anesthesia delivery unit with electronically controlled ventilator, gas delivery and agent vaporizing units.
CODE Serial Numbers: 40022203 and above.
MANUFACTURER Datex-OHMEDA, Inc., Tewksbury, Massachusetts.
DISRIBUTION Nationwide and international.
QUANTITY 1,150 units were distributed.
REASON The device has reliability problems with fresh gas delivery, agent delivery and ventilation functions.

PRODUCT CeeOn Intraocular Lens, heparin surface modified IOL.
CODE Model 727C, Lot Numbers: 5448, 5450, 5451, 5452, 5453, 5454, 5455, 5456, 5458, 5459, 5460, 5462, 5464, 5466.
MANUFACTURER Pharmacia & Upjohn Groningen BV, Groningen, Netherlands.
RECALLED BY Pharmacia & Upjohn Company, Kalamazoo, Michigan
DISTRIBUTION Arizona, Arkansas, California, Idaho, Ohio.
QUANTITY 140 lenses were distributed.
REASON The label states the lens has a diameter of 6.5mm while the actual diameter of the lens is 6.0mm.