Recalls / —
—#173414
Product
K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
- FDA product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Lot Numbers: 187764 193497 193567 232280 232683 232684 232685 232686 233858 234049 235477 BFI0LJ8 BFI0M5B BFI0MAV BFI0N16 BFI0NNN I0N17 I0N18 BFI0LJ8R BFI0MAVR BF10LJ8 BF10MAV BFIOLI8 I0NNN
Why it was recalled
There is a potential for weak seals of the sterile packaging.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Urgent Medical Device Recall notification letters dated 5/28/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. 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.
Recalling firm
- Firm
- Zimmer Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- Worldwide Distribution - US Nationwide: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH OK, OR, PA, SC, TN, TX, UT, WA, WI, WV, and Puerto Rico. Products were distributed to the following foreign countries: Australia, Canada, Chile, Japan, Netherlands.
Timeline
- Recall initiated
- 2019-05-28
- Terminated
- 2021-11-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #173414. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.