Recall Z-0538-2019 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
Zimmer Natural Nail System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2490-097-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
| Date | Oct 22, 2018 |
| Status | Terminated |
| Reason | Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility |
| Root cause | Packaging process control |
| Action | Zimmer Biomet conducted recall to distributors and hospital risk managers on 10/22/18, distributors notified via email. Hospital risk managers, as well as distributors with product, will be notified via Fed'X." Distributors responsibilities include:- Locating and removing the product in their territory, as well as identifying hospitals with fielded inventory. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers will be provided with a letter identifying the issue and their re |
| Quantity | 57241 |
| Distribution | Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.