Recall Z-1468-2022 ยท HTY Pin, Fixation, Smooth
Paragon 28, Inc.
HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
| Date | May 26, 2022 |
| Status | Open, Classified |
| Reason | Due to Titanium plasma coating not present implant. |
| Root cause | Under Investigation by firm |
| Action | On 05/26/2022, the firm communicated via email to its customers/distributors informing them that Paragon 28 has identified via customer complaints that the titanium plasma coating is missing on the HammerTube Implants. On 06/15/2022, Paragon28 communicated an updated "URGENT Medical Device Recall" letter to customer that informed them of the potential health risks involved with the affected devices such as: " The defect may cause the implant to potentially result in reduced of pull-out force creating instability at the joint which may lead to delayed or lack of healing. " The implants, with t |
| Quantity | 9 implants |
| Distribution | U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171715 | HammerTube System Paragon 28, Mar 5, 2018 |