CLASS II ONGOING Device recall · Reported 9 Nov 2022 · FDA Enforcement Report
Stratafix Spiral Pga-pcl Uni Ud Usp2-0(m3) S/a Sh recalled by Ethicon
Ethicon is recalling Stratafix Spiral Pga-pcl Uni UD USP2-0(M3) S/A SH. indicated for use in soft tissue. The recall was initiated on 20 Sep 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-0150-2023
- FDA event ID
- 90890
- Recalling firm
- Ethicon, Somerville, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Sep 2022
- FDA classified
- 31 Oct 2022
- Reported
- 9 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Surgical Instruments
Timeline
| 20 Sep 2022 | Recall initiated by company | |
| 31 Oct 2022 | Classified by FDA | +41 days |
| 9 Nov 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
Where it was distributed
International distribution of the country of China.
Questions about this recall
Why was it recalled?
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
Which lots are affected?
UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026
Where was it sold?
International distribution of the country of China.
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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