CLASS II ONGOING Device recall · Reported 29 Dec 2021 · FDA Enforcement Report
Stryker Darco Screw, Locking, Ti6A14V recalled
Wright Medical Technology is recalling Stryker Darco Screw, Locking, Ti6A14V, distributed in 7 states. The recall was initiated on 3 Dec 2021 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-0393-2022
- FDA event ID
- 89089
- Recalling firm
- Wright Medical Technology, Arlington, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Dec 2021
- FDA classified
- 17 Dec 2021
- Reported
- 29 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 3 Dec 2021 | Recall initiated by company | |
| 17 Dec 2021 | Classified by FDA | +14 days |
| 29 Dec 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The incorrect product is contained in the packaging.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
Where it was distributed
Worldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The countries of Canada, France, Germany, Lebanon, The Netherlands, Saudi Arabia, and United Kingdom.
Questions about this recall
Why was it recalled?
The incorrect product is contained in the packaging.
Which lots are affected?
Lot #1643355
Where was it sold?
Worldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The countries of Canada, France, Germany, Lebanon, The Netherlands, Saudi Arabia, and United Kingdom.
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 89089| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Stryker Claw II Ortholoc 3DSi Plate, Hole Qty recalled | Wright Medical Technology | Packaging Defects | 7 states |
More recalls from Wright Medical Technology
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Charlotte Claw Screw recalled by Wright Medical Technology | Wright Medical Technology | Other | Nationwide |
| 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 |
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| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |