A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
FDA Recall Z-2315-2020 · Posted None
Recalling FirmBiomet
Recall StatusTerminated
Product CodeHRS
Date Initiated2020-05-14
Date Terminated2021-04-08
Product Quantity1 US and 1 OUS
Reason for Recall
Distributed to the field without having completed design history files or design transfer activities
Firm Action
Zimmmer Biomet issued Urgent Medical Device Recall letter , dated May 14, 2020 to Risk Manger, Distributors,Surgeons, stating reason for recall, health risk and action to take:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form will be returned even if you do not have affected products at your facility.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
Surgeon Responsibilities:
1. Review this notification for awareness of the contents.
2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
Root Cause
Device Design
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.