CLASS II Device recall · Reported 4 Dec 2019 · FDA Enforcement Report
Ortholoc 3DI Plt Sys Sterile, Locking Screw, 3.5 Sterile recalled
Wright Medical Technology is recalling Ortholoc 3DI Plt Sys Sterile, Locking Screw, 3.5 Sterile. The recall was initiated on 8 Nov 2016 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-0563-2020
- FDA event ID
- 84180
- Recalling firm
- Wright Medical Technology, Arlington, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Nov 2016
- FDA classified
- 25 Nov 2019
- Reported
- 4 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 8 Nov 2016 | Recall initiated by company | |
| 25 Nov 2019 | Classified by FDA | +1112 days |
| 4 Dec 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm discovered a lack of adequate documentation confirming sterility on certain products.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
Where it was distributed
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Questions about this recall
Why was it recalled?
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Which lots are affected?
Lot Number 1568030
Where was it sold?
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
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
11 other products · FDA event 84180This product is part of a recall event; the main page for the event is Pro-stim 10cc Injectable recalled by Wright Medical Technology.
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 |
Other Other Medical Devices recalls
All 13,884| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| 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 |