Z-0525-2020Class II

Comprehensive RS Cleat CAP, Item No. 110300

Name: Z-0525-2020 Comprehensive RS Cleat CAP, Item No. 110300
Creator: Zimmer Biomet, Inc.
Published: 2019-08-21
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-08-21 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Comprehensive RS Cleat CAP, Item No. 110300 on 2019-08-21. FDA classified it as Class II and gives the reason as "Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0525-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-21
Posted: 2019-11-22
Terminated: 2021-07-21
Recalling firm: Zimmer GmbH
Product: Comprehensive RS Cleat CAP, Item No. 110300
Product code: NA
Reason for recall: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected]. 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.
Product codes and lots: 126590 126600 502890 502900 502910 012080 941080

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0525-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0519-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0520-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0521-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0522-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0523-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0524-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0525-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0526-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0527-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0528-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0529-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0530-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0531-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0532-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22
Z-0533-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-22

Product code NA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)