Home / Recalls / Ethicon, Inc. / Z-2533-2018

Z-2533-2018 Class II Terminated

Recalled by Ethicon, Inc. — Somerville, NJ

Recall Details

Product Type
Devices
Report Date
August 1, 2018
Initiation Date
June 8, 2018
Termination Date
September 25, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
756

Product Description

PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)

Reason for Recall

Products do not meet a tensile strength specification

Distribution Pattern

Japan

Code Information

Lot Number:MCZ162

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  • Z-0319-2025 Class II — Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product N (September 25, 2024)
  • Z-2144-2024 Class II — VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue appro (May 10, 2024)
  • Z-2145-2024 Class II — VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in genera (May 10, 2024)
  • Z-2148-2024 Class II — MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue ap (May 10, 2024)
  • Z-2147-2024 Class II — PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft (May 10, 2024)