Mixing Bowl and Spatula, 20-pack

Brief description of the problem (reason for recall)

This recall has been initiated issue is related to a supplier packaging process that potentially resulted in the devices not maintaining a sterile barrier.

Advice for health professionals and distributors:

1. Review this Field Safety Notice and ensure that affected personnel are aware of the contents.
2. Immediately locate and quarantine any affected product in your inventory. Your Zimmer Biomet sales representative may assist with removing the affected product(s) from your facility.
3. If any affected product has been further distributed, provide your customer(s) with this Field Safety Notice and ensure documentation.
4. Complete Attachment 1 (on Customer Recall Letter) – Certificate of Acknowledgement and send it to fieldaction.africa@zimmerbiomet.com . This form must be returned even if you do not have any affected product available for return.
5. Retain a copy of Attachment 1 – Certificate of Acknowledgement with your records in the event of a compliance audit of your facility.
6. If you have further questions or concerns after reviewing this Field Safety Notice, please contact your local Zimmer Biomet representative.

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.