Ethicon, Inc. recalls PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use…
knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage
Read the official notice →- Date
- 2022-12-21
- Country
- United States
- Brand
- Ethicon
- Product
- PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use…
- Classification
- Class II
- Units
- International (OUS) only: Canada, Japan, Australia and New Zealand
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Ethicon recalls
- 2024-04-24
USEthicon, Inc. recalls STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM)…
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
- 2023-09-27
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ETHICON, LLC recalls PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50,…
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
- 2023-05-17
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Ethicon, Inc. recalls PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft…
Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
FDA · DeviceEthicon, Inc.International distribution in the countries of United Kingdom, Ireland and…Official notice → - 2022-11-09
- US
Ethicon, Inc. recalls 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…
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
- 2022-09-28
- US
Ethicon, Inc. recalls PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Product may contain the incorrect material which could impact treatment.
- 2022-05-18
- US
Ethicon, Inc. recalls 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:…
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Other drugs & medical recalls in the United States
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- US
DeRoyal Industries Inc recalls DeRoyal CATARACT PACK CSM, REF 89-6863
DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
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NuVasive Specialized Orthopedics, Inc. recalls NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of…
During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the…
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FDA · DeviceStradis Medical, LLC dba Stradis HealthcareUS nationwide distribution, and Canada.Official notice → - US
Stryker Medical Division of Stryker Corporation recalls Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)
Cot may experience unintended motion due to damaged cables. Potential risk of soft tissue injury to patients such as scrapes or bruises resulting from the cot lowering faster than expected.
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