DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Reported: March 25, 2020 Initiated: February 18, 2019 #Z-1505-2020
Product Description
DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
Reason for Recall
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.
Details
- Recalling Firm
- TeDan Surgical Innovations LLC
- Units Affected
- Total 57 boxes (49 boxes for Lot 2017111301 and 48 boxes for Lot 2018031401)
- Distribution
- Worldwide.
- Location
- Sugar Land, TX
Frequently Asked Questions
What product was recalled? ▼
DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.. Recalled by TeDan Surgical Innovations LLC. Units affected: Total 57 boxes (49 boxes for Lot 2017111301 and 48 boxes for Lot 2018031401).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2020. Severity: Moderate. Recall number: Z-1505-2020.
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