FDA Recall Terminated

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Recall: Z-0520-2020 · Initiated August 21, 2019

Recall

Recall Number: Z-0520-2020
Event Number: 83783
Firm: Zimmer Biomet, Inc.
FEI Number: 1825034
Product Code: KWS
Status: Terminated
Root Cause: Environmental control
Initiated: August 21, 2019
Terminated: July 21, 2021
Address: 56 E Bell Dr, Warsaw, IN, 46582-6989

Description

Reason

Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

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 [email protected]. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.

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.

Quantity

219988 units