| Class 2 Device Recall Custom Product | |
Date Initiated by Firm | August 21, 2019 |
Create Date | November 22, 2019 |
Recall Status1 |
Terminated 3 on July 21, 2021 |
Recall Number | Z-0522-2020 |
Recall Event ID |
83783 |
Product Classification |
unknown device name - Product Code NA
|
Product | HENNESSY LEFT CONST GLENOID HA, Item No. PM555360
UDI (01)00880304819597(17)260425(10)664030
Product Usage: Constrained Shoulder. |
Code Information |
664030 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
|
For Additional Information Contact | 411 Technical Services 574-371-3071 |
Manufacturer Reason for Recall | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
FDA Determined Cause 2 | Environmental control |
Action | On September 11, 2019, the firm began notifying distributors and customers of the recall via an Urgent Medical Device Recall letter. The letter informed consignees of the product issue.
Customers were asked to assist their Zimmer Biomet sales representative and quarantine all identified product. The sales representative will remove the product from your facility. If any products were further distributed, please forward the notification to responsible parties.
If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00 pm ET, 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 CorporateQuality.PostMarket@zimmerbiomet.com.
There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. |
Quantity in Commerce | 219988 units (total) |
Distribution | US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela. |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|