CLASS II ONGOING Device recall · Reported 21 Jun 2023 · FDA Enforcement Report
Wand Reader recalled by p-Chip
p-Chip is recalling p-Chip Wand Reader, distributed nationwide in the US. The recall was initiated on 3 Mar 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-1693-2023
- FDA event ID
- 92483
- Recalling firm
- p-Chip, Chicago, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Mar 2021
- FDA classified
- 12 Jun 2023
- Reported
- 21 Jun 2023
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 3 Mar 2021 | Recall initiated by company | |
| 12 Jun 2023 | Classified by FDA | +831 days |
| 21 Jun 2023 | 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 laser operation might fall under a higher laser class.
Product as listed by the FDA
p-Chip Wand Reader
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Wand Reader recalled?
Yes. p-Chip recalled Wand Reader on 3 Mar 2021. The recall is Class II and its status is Ongoing. Recall number Z-1693-2023.
Why was it recalled?
The laser operation might fall under a higher laser class.
Which lots are affected?
Model: WA-4000, 4500, -8000, and -8500
Where was it sold?
US Nationwide Distribution
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 21 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 Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |