Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 ETS-V. PSD-V is an implantable surg

FDA device recall Z-0891-05 · posted 2005-06-14 · Terminated

Recall details

Recalling firm

Synovis Surgical Inovation Div. of

Reason for recall

Device is contained in 2 pouches. The outer pouch's seal may be compromised; this may render the exterior of the interior pouch non-sterile.

Action taken

The sites and/or distributors that received the suspect devices were contacted by telephone and given instruction how to return/replace the devices. A Recall Notice, dated 05/31/05, was also sent to customers indicating the model number(s) and quantities of affected product which the institution received and the amount they were to return.

Root cause

Other

Status

Terminated

Product code

FTM

Quantity affected

320 boxes each box containing 6 pouches

Distribution

AK, AL, AZ, CA, DE, FL, GA, MO, OR, TN, TX, VA and WA

Date initiated

2005-05-23

Date posted

2005-06-14

Date terminated

2005-11-17

Location

Saint Paul, MN