Medical device recalls Moderate risk

In2bones USA, LLC recalls NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010

Recall date
November 14, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0670-2019
FDA classification
Class II
Brand / firm
In2bones USA, LLC
Sold / distributed
TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

Get recall alerts

Free email alert whenever In2bones USA, LLC has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: In2bones USA, LLC