Recall Z-0670-2019— In2bones USA, LLC

Name: FDA recall Z-0670-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-14

Class II · Terminated

Class II FDA medical device recall by In2bones USA, LLC, initiated 2018-11-14, terminated 2019-05-08. It names one FDA 510(k) clearance: K161426. Product: NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010. Reason: The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit..

Recalling firm: In2bones USA, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-11-14
Terminated: 2019-05-08
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K161426 — NeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC·cleared 2016-10-24

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

NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010

Reason for recall

The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit.

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