CLASS II Device recall · Reported 16 Oct 2019 · FDA Enforcement Report

Stratafix Spiral PDS Plus Violet 18 CT-1 Needle Product recalled

Ethicon is recalling Stratafix Spiral PDS Plus Violet 18 CT-1 Needle Product, distributed in 14 states. The recall was initiated on 13 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # LPH946 GTIN: 10705031235823

Quantity recalled416 each

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-0047-2020
FDA event ID: 83715
Recalling firm: Ethicon, Somerville, NJ
Classification: Class II
Status: Terminated
Recall initiated: 13 Aug 2019
FDA classified: 4 Oct 2019
Reported: 16 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

13 Aug 2019	Recall initiated by company
4 Oct 2019	Classified by FDA	+52 days
16 Oct 2019	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

The product does not meet certain internal strength testing specifications.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture

Where it was distributed

States: IN MD AR IL GA TN NJ PA NC CA OK CO KS UT KY WA OH OR OUS: Australia Hong King India Japan Korea Singapore Thailand United States

Arkansas California Colorado Georgia Illinois Kansas Kentucky Maryland North Carolina New Jersey Pennsylvania Tennessee Utah Washington

Questions about this recall

Is Stratafix Spiral PDS Plus Violet 18 CT-1 Needle Product recalled?

Yes. Ethicon recalled Stratafix Spiral PDS Plus Violet 18 CT-1 Needle Product on 13 Aug 2019. The recall is Class II and its status is Terminated. Recall number Z-0047-2020.

Why was it recalled?

The product does not meet certain internal strength testing specifications.

Which lots are affected?

Lot # LPH946 GTIN: 10705031235823

Where was it sold?

States: IN MD AR IL GA TN NJ PA NC CA OK CO KS UT KY WA OH OR OUS: Australia Hong King India Japan Korea Singapore Thailand United States

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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