Safety information on the medical device KLASSIKER forearm crutches, models 220 and 230
The Federal Office for Safety in Health Care (BASG) warns against breaking KLASSIKER forearm crutches, models 220 and 230. Only certain LOT numbers are affected.
It has been determined that the forearm crutches may be affected by a technical defect that could lead to a sudden breakage. This defect could lead to serious falls and resulting serious injuries.
The affected forearm crutches were issued in Austria from May 2022 in the colors blue and black. They can be identified by the LOT number on the MDR label attached to the tube of the forearm walking aid (see example below).
The following LOT numbers starting with "PA" are affected:
- 772143
- 772144
- 772854
- 772893
- 772895
According to current estimates, around 35 of the above products are affected in Austria.
The BASG has so far received 0 reports of cases of damage from Austria from the period in question.
Medical devices | forearm crutches KLASSIKER Models 220 and 230 |
---|---|
Manufacturer | Ossenberg GmbH |
Batch number(s) | Affected LOT numbers: PA 772143, PA 772144, PA 772854, PA 772893, PA 772895 |
Corrective actions | The BASG recommends checking the LOT numbers of the forearm crutches to ensure safety. If a forearm crutch is affected, it can be returned to the supplier. Please stop using the affected forearm crutch immediately to avoid possible health risks from falls due to a sudden breakage. If you have identified an affected forearm crutch using the LOT number, you can obtain a replacement product from your supplier. |
Depth of recall | Patients |
Further information Link |
Rückfragen (fachlich): Dr. Christoph Baumgärtel, Tel.: +43 505 55-36004 E-Mail: christoph.baumgaertel@ages.at Rückfragen (für Medien): Kommunikationsmanagement, Tel.: +43 505 55-25000 E-Mail: presse-basg@basg.gv.at |
Company letter (pdf) Link | Safety notice |