PDS II Surgical Sutures Recalled for Tensile Strength Defect
ETHICON is recalling specific lots of PDS II surgical sutures after internal testing confirmed some units did not meet tensile strength requirements. Approximately 868,363 units were distributed in the United States and globally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a confirmed manufacturing defect in a critical surgical device. No adverse events or injuries are reported in the source text. The defect poses a risk of harm to surgical patients, meeting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
ETHICON, LLC is recalling specific lots of PDS II (polydioxanone) sutures. Approximately 868,363 units from the affected lots were distributed in the United States and globally. Internal testing confirmed that some units from these lots did not meet the required tensile strength standard.
Surgical sutures that do not meet tensile strength requirements may not properly support surgical wounds and could compromise the effectiveness of wound closure.
Healthcare facilities and providers should immediately discontinue use of the affected product lots. Patients who received sutures from these lots should contact their healthcare provider with any concerns about wound healing or complications. The FDA website provides detailed information about affected product numbers and lot numbers.
The recalled product
- Product
- PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z259H-50, Z416H-50, Z
- Manufacturer
- ETHICON, LLC
- Hazard
- tensile-strength-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 10705031026742
- 10705031031234
- 10705031032620
- 10705031033894
- 10705031134386
- 10705031134492
- 10705031118102
- 10705031073487
- 10705031149410
- 10705031149427
- 10705031075443
- 10705031149441
- 10705031149472
- 10705031086906
- 10705031130296
- 10705031130302
- 10705031082960
- 10705031151819
- 10705031130333
- 10705031130357
Distribution
Distributed nationwide across the United States.
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