FDA-Device2018-12-12Class II
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Zimmer Biomet, Inc.
Hazard
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Sold states
Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN
Affected count
1676
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0542-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief