CLASS II Device recall · Reported 19 Aug 2020 · FDA Enforcement Report
Hardware removal kit recalled by Wright Medical Technology
Wright Medical Technology is recalling Hardware removal kit, distributed nationwide in the US. The recall was initiated on 28 Jul 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2796-2020
- FDA event ID
- 85982
- Recalling firm
- Wright Medical Technology, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jul 2020
- FDA classified
- 13 Aug 2020
- Reported
- 19 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 28 Jul 2020 | Recall initiated by company | |
| 13 Aug 2020 | Classified by FDA | +16 days |
| 19 Aug 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Hardware removal kit, Part Number 1985KIT1 - 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.
Where it was distributed
US Nationwide distribution including in the states of CO, TX, OR, KX, SC, CA, AR, NJ, UT, VA, MO, NC, FL, IL.
Nationwide ArkansasCaliforniaColoradoFloridaIllinoisMissouriNorth CarolinaNew JerseyOregonSouth CarolinaTexasUtahVirginia
Questions about this recall
Why was it recalled?
Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
Which lots are affected?
Lot Codes: 01 through 64, 66 and 67
Where was it sold?
US Nationwide distribution including in the states of CO, TX, OR, KX, SC, CA, AR, NJ, UT, VA, MO, NC, FL, IL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85982This product is part of a recall event; the main page for the event is Screw Removal Case Assembly recalled by Wright Medical Technology.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Screw Removal Case Assembly recalled by Wright Medical Technology | Wright Medical Technology | Device Malfunction | Nationwide |
More recalls from Wright Medical Technology
All 78| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | stryker Infinity Resection Adjustment Block recalled | Wright Medical Technology | Other | NE, TX |
| Device | CLASS II | Stryker Infinity Alignment Frame Distal Sub-Assembly recalled | Wright Medical Technology | Device Malfunction | TN |
| Device | CLASS II | stryker Ortholoc 3Di Fusion Plate MTP Right recalled | Wright Medical Technology | Other | Nationwide |
| Device | CLASS II | stryker Ortholoc 3Di Fusion Plate MTP Right recalled | Wright Medical Technology | Other | Nationwide |
| Device | CLASS II | Ortholoc 3DSi Claw II 4 Hole Plate, Size recalled | Wright Medical Technology | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,212| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |