CLASS II ONGOING Device recall · Reported 18 May 2022 · FDA Enforcement Report
Stratafix Spiral Pga-pcl Uni UD sizes recalled by Ethicon
Ethicon is recalling Stratafix Spiral Pga-pcl Uni UD sizes: [ USP2-0(M3) S/A Rb-1. The recall was initiated on 24 Mar 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-1053-2022
- FDA event ID
- 90016
- Recalling firm
- Ethicon, Somerville, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Mar 2022
- FDA classified
- 10 May 2022
- Reported
- 18 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 24 Mar 2022 | Recall initiated by company | |
| 10 May 2022 | Classified by FDA | +47 days |
| 18 May 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
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
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 sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
Where it was distributed
International distribution in the country of China.
Questions about this recall
Why was it recalled?
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Which lots are affected?
Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049
Where was it sold?
International distribution in 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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