| | Class 2 Device Recall Screw Removal Case Assembly |  |
| Date Initiated by Firm | July 28, 2020 |
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| Create Date | August 13, 2020 |
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| Recall Status1 |
Terminated 3 on November 16, 2022 |
| Recall Number | Z-2797-2020 |
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| Recall Event ID |
85982 |
| Product Classification |
General surgery tray - Product Code LRO
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| Product | Screw Removal Case Assembly, Part Number 1985BASE - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument. |
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| Code Information |
product is not lot coded |
| FEI Number |
3010667733
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Recalling Firm/
Manufacturer |
Wright Medical Technology, Inc.
1023 Cherry Rd
Memphis TN 38117-5423
|
| For Additional Information Contact | Kevin C. Smith
901-867-9971 |
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Manufacturer Reason
for Recall | Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. |
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FDA Determined
Cause 2 | Device Design |
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| Action | Wright disseminated the notices by Fed Ex and email on 07/28/2020. The notices requested the following actions:
" Cease using the screw and driver combinations: Dart-Fire 2.5mm Headless Screw with HCS-056-25 1.5 Hex Driver and Dart-Fire 3.0mm Headless Screw and 44112001 2.0 Hex Driver
" Disseminate this notice to all those who need to be aware within your organization.
" Ensure that you have the right products for removal surgery through pre-operative planning and coordinating with your Wright Medical Representative.
The firm will provide a new kit when available. |
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| Quantity in Commerce | 9 units |
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| Distribution | US Nationwide distribution including in the states of CO, TX, OR, KX, SC, CA, AR, NJ, UT, VA, MO, NC, FL, IL. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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