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Terminated

Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only, Synovis Surgical Innovations, A Division of Synovis Life Technologies, Inc, 2575 University Ave W., St Paul, MN 55114-1024. The device is intended to be used as a staple line buttress

FDA Recall Z-0274-2012 · Posted 2011-11-23

Recalling FirmSynovis Surgical Inovation Div. of
Recall StatusTerminated
Product CodeFTM
Date Initiated2011-10-26
Date Terminated2012-04-24
Product Quantity132 units

Reason for Recall

Synovis Surgical Innovations is voluntarily recalling one lot of Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) product because some of the devices were mislabeled.

Firm Action

Synovis Surgical Inovation sent a "Recall Notification" letter dated October 26, 2011. The letter described the problem and product affected. Customers were instructed to identify and quarantine the affected product and to complete and fax the Product Return/Replacement Form.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution including CT, GA, NJ, NY, OH, TX, VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041669VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSDSynovis Surgical Innovations · 2004-10-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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