FDA recall Z-0150-2023

Product

STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12

Reason for recall

Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair

Distribution

International distribution of the country of China.

Key facts

Status

Ongoing

Initiation date

2022-09-20

Report date

2022-11-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0150-2023