CLASS II ONGOING Device recall · Reported 8 Mar 2023 · FDA Enforcement Report
Ortholoc 3DSi Claw II 4 Hole Plate, Size recalled
Wright Medical Technology is recalling Ortholoc 3DSi Claw II 4 Hole Plate, Size, distributed nationwide in the US. The recall was initiated on 2 Feb 2023 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-1169-2023
- FDA event ID
- 91673
- Recalling firm
- Wright Medical Technology, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Feb 2023
- FDA classified
- 24 Feb 2023
- Reported
- 8 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 2 Feb 2023 | Recall initiated by company | |
| 24 Feb 2023 | Classified by FDA | +22 days |
| 8 Mar 2023 | 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
Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.
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
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
Where it was distributed
US Nationwide distribution in the state of NY.
Questions about this recall
Why was it recalled?
Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.
Which lots are affected?
GTIN 00840420152985, Lot Number 1636048
Where was it sold?
US Nationwide distribution in the state of NY.
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 91673This product is part of a recall event; the main page for the event is Ortholoc 3DSi Claw II 4 Hole Plate, Size recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ortholoc 3DSi Claw II 4 Hole Plate, Size recalled | Wright Medical Technology | Packaging Defects | Nationwide |
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