Reported Jun 21, 2017 · Terminated
Sutures. ENDO STITCH
Medtronic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
Sutures. ENDO STITCH
4 of 4 products
| Model / number | Product as published |
|---|---|
170056 | ENDO STITCH POLYSORB 0 48" U/D DLU SU |
170052 | ENDO STITCH POLYSORB 0 48" VIO DLU SU |
170057 | ENDO STITCH POLYSORB 2/0 48" U/D DLU SU |
170053 | ENDO STITCH POLYSORB 2/0 48" VIO DLU SU |
- Lot codes and dates
- ENDO STITCH* POLYSORB* 0 48" U/D DLU SU J4M0853X J4M0855X J5A0192X ENDO STITCH* POLYSORB* 0 48" VIO DLU SU J4L1477X ENDO STITCH*POLYSORB* 2/0 48" U/D DLU SU J5A1097X ENDO STITCH*POLYSORB* 2/0 48" VIO DLU SU J5A0702X J5A0703X J5A0704X J5A0705X J5A1206X J5A1207X
- Amount recalled
- 478,465 (total for all products)
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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