Device product
RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill.
Z-0631-2021
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 86896
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7428
- Official record key
device-enforcement:Z-0631-2021
Official wording
Reason: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Code information: Lots 492670 562350 253280 253290 253300 278210 278230 417030 608110 608150 677300 253320 267910 267920 267930 267940 267960 267970 278160 363700 363720 363740 386960 492750 507930 507940 507980 508000 232590 232610 386830 386850 386860 386870 492720 530950 386840
Distribution pattern: Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
Derived failure modes
-
Sterility assurance
loss of sterility