Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Reported: December 12, 2018 Initiated: October 22, 2018 #Z-0537-2019
Product Description
Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Reason for Recall
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 48320
- Distribution
- Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.. Recalled by Zimmer Biomet, Inc.. Units affected: 48320.
Why was this product recalled? ▼
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 12, 2018. Severity: Moderate. Recall number: Z-0537-2019.
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