Z-0524-2020Class II

Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263

Name: Z-0524-2020 Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263
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 HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A 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-0524-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-21
Posted: 2019-11-22
Terminated: 2021-07-21
Recalling firm: Zimmer GmbH
Product: Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/A
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: 062090 062100 062110 062120 104880 116920 119760 973400 973410 062130 104890 933090 933100 933110 062140 502750 933120 933130 044510 045880 045890 202520 502780 109560 689770 710510 710520 736700 736710 762300 762310 781930 781940 806540 806550 838070 838080 853100 853110 870190 870200 886220 886230 901510 901520 933070 933080 948630 948640 689780 710530 710540 736720 736730 762320 762330 781950 781960 781970 806560 806570 806580 838090 838100 838110 853120 853130 870210 870220 886240 886250 901530 901540 689790 710550 710570 736740 736750 762340 762350 781990 782000 806590 806610 838120 838130 853140 853150 870230 870240 886260 886270 901550 901560 015610 015620 156580 689820 710580 710590 736760 736770 762360 782010 782020 806620 806630 838140 838150 853160 853170 870260 870270 886290 886300 901570 901580 933150 933160 948650 948660 973420 973430 994730 994740

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0524-2020
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)