Recall Z-0008-2023— Synthes (USA) Products LLC

Name: FDA recall Z-0008-2023
Creator: U.S. Food and Drug Administration
Published: 2022-08-30

Class II · Ongoing

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2022-08-30. It names one FDA 510(k) clearance: K191463. Product: Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001. Reason: Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound.

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-08-30
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K191463 — DePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLC·cleared 2020-02-26

K-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

Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001

Reason for recall

Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound

Data sourced from openFDA. This site is unofficial and independent of the FDA.