Recall Z-0542-2019— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-10-22, terminated 2020-12-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility.
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-22
- Terminated
- 2020-12-30
- Firm location
- Warsaw, IN, United States
Product description
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.