CLASS II ONGOING Device recall · Reported 24 Apr 2024 · FDA Enforcement Report
Stratafix Spiral Monocryl Plus BI UD 12+(30+ USP3-0(M2) D/A recalled
Ethicon is recalling Stratafix Spiral Monocryl Plus BI UD 12+(30+ USP3-0(M2) D/A PS Prm- Indicated for use in, distributed in 9 states. The recall was initiated on 8 Mar 2024 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-1533-2024
- FDA event ID
- 94220
- Recalling firm
- Ethicon, Raritan, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Mar 2024
- FDA classified
- 12 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 8 Mar 2024 | Recall initiated by company | |
| 12 Apr 2024 | Classified by FDA | +35 days |
| 24 Apr 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
Where it was distributed
CO GA IA MI NJ NY NY PA SC WI
ColoradoGeorgiaIowaMichiganNew JerseyNew YorkPennsylvaniaSouth CarolinaWisconsin
Questions about this recall
Why was it recalled?
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
Which lots are affected?
UDI/GTIN: 30705031464289 (box) 10705031464285 (pouch) Lot Number: SHBAEC Exp. Date: June 30, 2024
Where was it sold?
CO GA IA MI NJ NY NY PA SC WI
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.
More recalls from Ethicon
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stratafix Spiral PDS Plus Bidirectional Knotless Tissue recalled | Ethicon | Other | Nationwide |
| Device | CLASS II | Perma-hand Silk Suture recalled by Ethicon | Ethicon | Sterility | Nationwide |
| Device | CLASS II | Ethibond Excel Polyester Suture recalled by Ethicon | Ethicon | Sterility | Nationwide |
| Device | CLASS II | Prolene Polypropylene Suture recalled by Ethicon | Ethicon | Sterility | Nationwide |
| Device | CLASS II | Monocryl" (poliglecaprone Suture recalled by Ethicon | Ethicon | Packaging Defects | 45 states |
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