Recall Z-2261-2018— Paragon 28, Inc.
Class II · Terminated
Class II FDA medical device recall by Paragon 28, Inc., initiated 2017-12-19, terminated 2021-01-15. It names one FDA 510(k) clearance: K170923. Product: P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.. Reason: Missing drill guide as stated in the package..
- Recalling firm
- Paragon 28, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-19
- Terminated
- 2021-01-15
- Firm location
- Englewood, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.
Reason for recall
Missing drill guide as stated in the package.
Data sourced from openFDA. This site is unofficial and independent of the FDA.