CLASS II Device recall · Reported 1 Aug 2018 · FDA Enforcement Report
PDS II (Polydioxanoe) Suture Dyed & Undyed-Pdsii Undyed recalled
Ethicon is recalling PDS II (Polydioxanoe) Suture Dyed & Undyed-Pdsii Undyed (18") 5- Armed PS-6 Prime Needle. The recall was initiated on 8 Jun 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2534-2018
- FDA event ID
- 80401
- Recalling firm
- Ethicon, Somerville, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jun 2018
- FDA classified
- 24 Jul 2018
- Reported
- 1 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 8 Jun 2018 | Recall initiated by company | |
| 24 Jul 2018 | Classified by FDA | +46 days |
| 1 Aug 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products do not meet a tensile strength specification
Product as listed by the FDA
PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)
Where it was distributed
Japan
Questions about this recall
Is PDS II (Polydioxanoe) Suture Dyed & Undyed-Pdsii Undyed (18") 5- Armed PS-6 Prime Needle recalled?
Yes. Ethicon recalled PDS II (Polydioxanoe) Suture Dyed & Undyed-Pdsii Undyed (18") 5- Armed PS-6 Prime Needle on 8 Jun 2018. The recall is Class II and its status is Terminated. Recall number Z-2534-2018.
Why was it recalled?
Products do not meet a tensile strength specification
Which lots are affected?
Lot Number: MCZ363
Where was it sold?
Japan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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