An Act To Require Notice for Orthopedic Medical Device Recalls
Maine Legislature, Session 130, LD 0804
Committee: Innovation, Development, Economic Advancement and Business
Sponsors: KEIM, ARFORD, BLACK, CLAXTON, STEWART, WOODSOME, JAVNER, MADIGAN, WHITE, ZAGER

Legislative Document
No. 804
S.P. 119
In Senate, March 5, 2021
An Act To Require Notice for Orthopedic Medical Device Recalls
Reference to the Committee on Innovation, Development, Economic Advancement and 
Business suggested and ordered printed.
DAREK M. GRANT
Secretary of the Senate
Presented by Senator KEIM of Oxford.
Cosponsored by Representative ARFORD of Brunswick and
Senators: BLACK of Franklin, CLAXTON of Androscoggin, STEWART of Aroostook, 
WOODSOME of York, Representatives: JAVNER of Chester, MADIGAN of Waterville, 
WHITE of Waterville, ZAGER of Portland.
Be it enacted by the People of the State of Maine as follows:
Sec. 1.  10 MRSA c. 232 is enacted to read:
CHAPTER 232
NOTIFICATION OF RECALL OF ORTHOPEDIC MEDICAL DEVICES
§1500-N. Notification of recall of orthopedic medical devices
1.  Definitions. As used in this chapter, unless the context otherwise indicates, the 
following terms have the following meanings.  
A.  "Firm" means the manufacturer or seller of an orthopedic medical device. 
B.  "Health care entity" means a hospital or ambulatory surgical facility as defined in 
Title 22, section 1812-E that is located in this State and that purchases an orthopedic 
medical device from a firm. 
C.  "Market withdrawal" has the same meaning as in 21 Code of Federal Regulations, 
Section 7.3 (2019).
D.  "Orthopedic medical device" means any device described in 21 Code of Federal 
Regulations, Part 888.
E.  "Recall" has the same meaning as in 21 Code of Federal Regulations, Section 7.3 
(2019).
2.  Patient notification required. Within 30 days after a health care entity receives 
notification of a recall or market withdrawal of an orthopedic medical device that it has 
provided to a patient, the health care entity shall provide a written notice to the patient of 
the recall or market withdrawal that includes the following information:
A.  Identification of the specific orthopedic medical device, including, if applicable, 
the lot number, code and serial number and any other pertinent descriptive information 
to enable accurate and immediate identification of the orthopedic medical device;
B.  A concise explanation of the reason for the recall or market withdrawal, to the 
extent known, and the hazards posed by the orthopedic medical device, if any;
C.  Specific action steps that the firm, health care entity or United States Food and Drug 
Administration advises the patient to take with respect to the orthopedic medical 
device; and
D.  A point of contact for the patient to obtain further information about the recall or 
market withdrawal and action steps under paragraph C.
3.  Civil violation.  An individual or health care entity that violates this chapter 
commits a civil violation.  The following penalties apply to violations of this chapter.
A.  An individual who violates this chapter commits a civil violation for which a fine 
of not less than $500 and not more than $5,000 may be adjudged for each violation.
B.  A health care entity that violates this chapter commits a civil violation for which a 
fine of not less than $2,000 and not more than $15,000 may be adjudged for each 
violation.
SUMMARY
This bill requires a hospital or ambulatory surgical facility to notify patients when the 
hospital or ambulatory surgical facility receives notice that an orthopedic medical device 
that the hospital or ambulatory surgical facility has provided to a patient has been subjected 
to market withdrawal or United States Food and Drug Administration requested recall. 
Notice must be provided to the patient in writing within 30 days and include identification 
of the specific device, a concise explanation of the reason for the recall and the hazards 
involved, if any, specific action steps and a point of contact for the patient.
The bill provides for a civil violation if an individual or entity fails to provide the 
notification.  An individual is subject to a fine of not less than $500 and not more than 
$5,000 for each violation, and an entity is subject to a fine of not less than $2,000 and not 
more than $15,000 for each violation.