Device product
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.
Z-0542-2019
Product summary
- Event
- Event 81394
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1676
- Official record key
device-enforcement:Z-0542-2019
Official wording
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Code information: All lots expiring prior to September 30, 2023
Distribution pattern: Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN
Derived failure modes
-
Unknown
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility