—#184787

Product

RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill.

FDA product code: HTW — Bit, Drill
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

On November 25, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the potential loss of sterility in affected devices. Customers were asked to do the following: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. All customers should also complete the certificate of acknowledgement included with the letter and return to the firm. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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

Timeline

Recall initiated: 2020-11-25
Posted by FDA: 2020-12-17
Terminated: 2024-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184787. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.