CLASS II ONGOING Device recall · Reported 1 Sep 2021 · FDA Enforcement Report
KeyPrint Soft recalled by Straumann USA
Straumann USA is recalling KeyPrint Soft, distributed nationwide in the US. The recall was initiated on 25 Jun 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-2336-2021
- FDA event ID
- 88427
- Recalling firm
- Straumann USA, Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jun 2021
- FDA classified
- 24 Aug 2021
- Reported
- 1 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 25 Jun 2021 | Recall initiated by company | |
| 24 Aug 2021 | Classified by FDA | +60 days |
| 1 Sep 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product label intended for the European community was distributed to the USA market via their US distribution organization
Product as listed by the FDA
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
Where it was distributed
US Nationwide distribution in the state of TX.
Questions about this recall
Why was it recalled?
Product label intended for the European community was distributed to the USA market via their US distribution organization
Which lots are affected?
Lot Number: KJ2858 Shelf Life (Expiration Date): 22 April 2023 Unique Device Identifier (UDI): +H66842200051/$$3230422KJ2858U
Where was it sold?
US Nationwide distribution in the state of TX.
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.
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| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
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