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Terminated

PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)

FDA Recall Z-2532-2018 · Posted None

Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeNEW
Date Initiated2018-06-08
Date Terminated2020-09-25
Product Quantity4992

Reason for Recall

Products do not meet a tensile strength specification

Firm Action

Johnson & Johnson Affiliate Japan notified consignees on 6/08/18 by customer letter through post or email or sales representative visits. Accounts requested to Examine inventory, remove and quarantine such product(s) and complete the Business Reply Form (BRF). Product to requested to be returned.

Root Cause

Under Investigation by firm

Distribution Pattern

Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061037PDS PLUS ANTIBACTERIAL SUTUREETHICON, Inc. · 2006-07-14

Official Source

View FDA Recall →

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

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