CLASS II ONGOING Device recall · Reported 28 Sep 2022 · FDA Enforcement Report
PDS II (polydioxanone) Suture, Product recalled by Ethicon
Ethicon is recalling PDS II (polydioxanone) Suture. The recall was initiated on 8 Aug 2022 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-1773-2022
- FDA event ID
- 90764
- Recalling firm
- Ethicon, Somerville, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Aug 2022
- FDA classified
- 20 Sep 2022
- Reported
- 28 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 8 Aug 2022 | Recall initiated by company | |
| 20 Sep 2022 | Classified by FDA | +43 days |
| 28 Sep 2022 | 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
Product may contain the incorrect material which could impact treatment.
Product as listed by the FDA
PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Where it was distributed
Distribution in Japan only
Questions about this recall
Why was it recalled?
Product may contain the incorrect material which could impact treatment.
Which lots are affected?
UDI-DI (GTIN): 10705031061705 (individual unit); 30705031061709 (sales unit box) Product Number: Z771D; Lot No: SAMPAL
Where was it sold?
Distribution in Japan only
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 26 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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