FDA recall Z-1053-2022

Product

STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].

Reason for recall

Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.

Distribution

International distribution in the country of China.

Key facts

Status

Ongoing

Initiation date

2022-03-24

Report date

2022-05-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1053-2022