Recall Z-0127-2019— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-08-08, terminated 2020-07-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures. Reason: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-08
- Terminated
- 2020-07-30
- Firm location
- Warsaw, IN, United States
Product description
Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number 814309360 Product Usage: Intended for the fixation of fractures
Reason for recall
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Data sourced from openFDA. This site is unofficial and independent of the FDA.