24 Aug INFrame™ Implant 2.0mm x 28mm and INFrame™ Implant 2.0mm x 34mm
| Company name & Address: | Registration number | Batch number(s) | Expiry date | Pack size | First Distribution date | Re-call Classification | Recall date |
| Medhold Medical (Pty) Ltd Block@Nature Office Park Block C3 472 Botterklapper Street
Die Wilgers Pretoria, Gauteng 0041 |
N/A |
22311-25 22311-32 |
N/A | Set
|
17 August 2023
|
Class III Type C | 21 August 2026 |
Brief description of the problem (reason for recall)
Acumed has initiated a Voluntary Recall to all field inventory for the INFrame™ Implants referenced in the table below, due to INFrame™ implant outer carton label indicated the implant was 28mm, but the inner pouch label indicated the implant was 34mm and from a different batch. The affected product shipments occurred between August 17, 2023, to April 30, 2025. To date, there have been no adverse events related to the issue reported.
Advice for health professionals and distributors:
According to the records, 1 quantity of the INFrame™ Implant 2.0mm x 34mm EXINF922034 batch 22311-32 was invoiced to your facility after use during surgery from the Ortho Trauma Loan Set CT0133. The sales order number SOMM138776, customer order AJ0405634, lot 22311-32. If any adverse event or product quality and safety issue occur(ed) with the used item, please report immediately to Medhold Medical or customercomplaints@acumed.net.
We appreciate your immediate attention and cooperation.
Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.