Reported Mar 25, 2020 · Terminated
DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by…
TeDan Surgical Innovations LLC
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: TeDan Surgical Innovations LLC · 12615 W Airport Blvd Ste 200 · Sugar Land, TX · 77478-6203
Is this the product you have?
- DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX
- STERILE - Product UsageThese products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers
- Lot codes and dates
- Item #: DS-0024 Lot #s: 2018022801 2018050801
- Amount recalled
- Total=146 boxes (48 boxes for Lot 2018022801 and 98 boxes for Lot 2018050801)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
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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