Health product recall

RapidFlap System, 12MM - 20MM RapidFlap SpinDown Clamp (2018-10-11)

Starting date:
October 11, 2018
Posting date:
November 30, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-68470

Affected products

RapidFlap System, 12MM - 20MM RapidFlap SpinDown Clamp

Reason

Zimmer Biomet is conducting a medical device recall for the spin down rapidflap for product manufactured prior to September 17, 2018 due to the nut that interfaces with the outer plate potentially being misassembled.

Affected products

RapidFlap System, 12MM - 20MM RapidFlap SpinDown Clamp

Lot or serial number

018970
018980
214680
768960

Model or catalog number

75-1020
75-1030
75-1040

Companies
Manufacturer

Biomet Microfixation, Inc.

1520 TRADEPORT DRIVE,

JACKSONVILLE,

32218

Florida

UNITED STATES