Reported Dec 22, 2021 · Ongoing
activforce 2 package labeling: Model: Activ5-M R 201-200563
Activbody, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Activbody, Inc. · 4435 Eastgate Mall · San Diego, CA · 92121-1982
Is this the product you have?
- activforce 2 package labelingModel: Activ5-M R 201-200563
- Lot codes and dates
- Activforce 2 Serial Numbers
1,715 of 1,715 codes
5M1011012046AK76555M1011012046AK75565M1011012046AK75575M1011012046AK75595M1011012046AK75605M1011012046AK75615M1011012046AK75625M1011012046AK75635M1011012046AK75645M1011012046AK75655M1011012046AK75665M1011012046AK75675M1011012046AK75685M1011012046AK75695M1011012046AK75705M1011012046AK75715M1011012046AK75725M1011012046AK75735M1011012046AK75745M1011012046AK75755M1011012046AK75765M1011012046AK75775M1011012046AK75785M1011012046AK75795M1011012046AK75805M1011012046AK75815M1011012046AK75825M1011012046AK75835M1011012046AK75845M1011012046AK75855M1011012046AK75865M1011012046AK75875M1011012046AK75885M1011012046AK75895M1011012046AK75905M1011012046AK75915M1011012046AK75925M1011012046AK75935M1011012046AK75945M1011012046AK75955M1011012046AK75965M1011012046AK75975M1011012046AK75985M1011012046AK75995M1011012046AK76005M1011012046AK76015M1011012046AK76025M1011012046AK76035M1011012046AK76045M1011012046AK76055M1011012046AK76065M1011012046AK76075M1011012046AK76085M1011012046AK76095M1011012046AK76105M1011012046AK76115M1011012046AK76125M1011012046AK76135M1011012046AK76145M1011012046AK7615
- Activforce 2 Serial Numbers
- Amount recalled
- 145 kits in U.S.
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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