Zimmer Biomet, Inc. Comprehensive RS Cleat CAP, Item No. 110300 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Comprehensive RS Cleat CAP, Item No. 110300
Brand
Zimmer Biomet, Inc.
Lot Codes / Batch Numbers
126590 126600 502890 502900 502910 012080 941080
Products Sold
126590 126600 502890 502900 502910 012080 941080
Zimmer Biomet, Inc. is recalling Comprehensive RS Cleat CAP, Item No. 110300 due to Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026