IA#89-10, ----5/29/92
TYPE OF ALERT: Automatic Detention
PRODUCT: Various implantable devices consisting in whole or in part
of Proplast, Proplast II, or Proplast HA including but not
limited to:
1. Preformed facial Implants
a. Ocular Globe
b. Zygomatic Implants
c. Malar Implants
d. Mandibular Angle Implants/and Condyle
e. Pre-Maxillary Implants
f. Chin Implants
g. Nasal Implants
h. Otoplasty/Ossicular
2. Blocks for facial and other reconstruction
3. Sheets for facial and other reconstruction
4. Temporomandibular Joint (TMJ) Implants
a. Glenoid Fossa
b. Condyle
c. Interpositional Implants
5. Orthopedic Implants
a. Staple Cushion Pad
b. Anaform Femoral Endoprosthesis
c. Tissue Cushion Pad
d. Trochanter Pad
e. Trapezium Implants
6. Custom Implants, i.e., mandible, forehead, maxilla,
pectus, orbital areas, as well as any other custom
configuration constructed of Proplast, Proplast II, and
Proplast HA.
PRODUCT
CODES : 76----
77----
87----
HARMONIZED
CODE : 9021
PROBLEMS : Inadequate directions/warnings (DVDW)
Violates 510(k) (DVTK)
Unapproved/Unfiled Premarket Approval (DVUU)
COUNTRIES : Switzerland (SW,855)
Netherlands (NL,630)
British Virgin Islands (VG,231)
MANUFACTURERS/
SHIPPERS : Promotus S A
Route De Divonne 48
Nyon, Switzerland
Ortomed, B.V.
Fruiteniersstraat 23
3334 Ka Zwinjndrecht
Netherlands
Hadaco, Ltd
British Virgin Islands
Tranquil Prospects
British Virgin Islands
Dynamax
British Virgin Islands
U.S. Manufacturers/Shippers include-
Oral Surgery Marketing, Inc., (OSMI),
Houston, Texas
John Prewitt, President
Novamed, Inc.,
Houston, Texas
Charles A. Homsy, President
CHARGES : All articles, charge:
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to be
a device, and that a notice or other information
respecting it was not provided as required by Section
510(k), [Misbranding, Section 502(o)]."
In addition, for the fossas, condyles, and
interpositional implants, charge:
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to be
a device which is misbranded in that it is dangerous to
health when used in the dosage or manner; or with the
frequency or duration prescribed, recommended, or
suggested in the labeling. [Misbranding, Section
502(j)]." AND
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to be
a device, the label of which fails to bear adequate
directions for use [Misbranding, Section 502(f)(1)]."
Additionally, for the hip implants, charge:
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to be
a Class III device without an approved PMA (Premarket
Approval) and is not exempt from such approval (i.e.,
Investigational Device Exemption,(IDE)), [Adulteration,
Section 501(f)(1)(B)]."
RECOMMENDING
OFFICE : Dallas District HFR-SW140
REASON FOR
ALERT : A series of inspections of the Houston based firms
beginning in March 1989 through February 1991,
disclosed numerous deviations from Good Manufacturing
Practices (GMP's) and from the Medical Device Reporting
Regulations (MDR's). The inspections also disclosed
that TMJ devices (fossa and condyle) were being
manufactured without benefit of marketing clearance,
i.e., 510(k); and that unapproved Class III hip
implants were being exported even though export
permission had been withdrawn.
Seizure actions were accomplished which prevented
additional distribution of adulterated and misbranded
devices. The seizure actions were upheld by court
rulings.
INSTRUCTIONS : Automatically detain, without sampling and analysis,
all implants which reference Proplast, Proplast II, or
Proplast HA, as indicated under "Product" Section.
When these products are detained, contact DAL-DO,
Compliance Branch at FTS 255-5317 or Commercial 214-
655-5317.
PRIORITIZATION
GUIDANCE : N/A
KEYWORDS : Proplast, Implants, Preformed, Prosthesis,
Reconstructive, TMJ, Cosmetic Surgery
FOI : No purging is necessary.
PREPARED BY : Linda Wisniowski, DIOP, 301-443-6553.
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