Z-1656-2020Class II

BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217

Name: Z-1656-2020 BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217
Creator: Biomet, Inc.
Published: 2020-02-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-02-26 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217 on 2020-02-26. FDA classified it as Class II and gives the reason as "Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters". 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-1656-2020
Classification: Class II
Status: Terminated
Initiated: 2020-02-26
Posted: 2020-04-03
Terminated: 2021-07-29
Recalling firm: Zimmer GmbH
Product: BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Reason for recall: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 2/26/2020, Zimmer Biomet sent an "Urgent Medical Device Recall" letter via FEDEX to direct sales distributors, hospitals, and surgeons. In addition, an email was sent to all distributors alerting them of the recall. Customers were instructed to quarantine the product and a Zimmer Biomet representative would remove the affected product from the facility. They asked customers to complete and return the "Certificate of Acknowledgement" form indicating whether they had any of the affected lots.
Quantity in commerce: 230,001
Distribution: Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.
Product codes and lots: ***Lot Numbers*** 919110, 191510, 414530, 650030, 931530, 836760, 836740, 162280, 162260, 285580, 285590, 668840, 036370, 390550, 613860, 518830, 555610, 207250, 913770, 628380, 286980, 336640, 057600, 143950, 329700, 115650, 737870, 732050, 191510R, 836740R, 118030, 302380, 302480, 378190, 766220, 021750, 021730, 921330, 162260R, 386330, 386300, 399990, 417210, 417220, 337710, 118030R,***UDI Numbers*** (01)00880304447158(17)190128(10)919110, (01)00880304447158(17)190201(10)191510, (01)00880304447158(17)191028(10)414530, (01)00880304447158(17)191001(10)650030, (01)00880304447158(17)191228(10)931530, (01)00880304447158(17)200328(10)836760, (01)00880304447158(17)200301(10)836740, (01)00880304447158(17)200828(10)162280, (01)00880304447158(17)200928(10)162260, (01)00880304447158(17)210328(10)285580, (01)00880304447158(17)210428(10)285590, (01)00880304447158(17)210928(10)668840, (01)00880304447158(17)221203(10)036370, (01)00880304447158(17)230821(10)390550, (01)00880304447158(17)230919(10)613860, (01)00880304447158(17)231209(10)518830, (01)00880304447158(17)231212(10)555610, (01)00880304447158(17)240518(10)207250, (01)00880304447158(17)241014(10)913770, (01)00880304447158(17)250325(10)628380, (01)00880304447158(17)250901(10)286980, (01)00880304447158(17)250914(10)336640, (01)00880304447158(17)260210(10)057600, (01)00880304447158(17)260510(10)143950, (01)00880304447158(17)260818(10)329700, (01)00880304447158(17)270627(10)115650, (01)00880304447158(17)270627(10)737870, (01)00880304447158(17)270825(10)732050, (01)00880304447158(17)190201(10)191510R, (01)00880304447158(17)200301(10)836740R, (01)00880304447158(17)271127(10)118030, (01)00880304447158(17)280301(10)302380, (01)00880304447158(17)280301(10)302480, (01)00880304447158(17)280315(10)378190, (01)00880304447158(17)280322(10)766220, (01)00880304447158(17)280417(10)021750, (01)00880304447158(17)280420(10)021730, (01)00880304447158(17)280430(10)921330, (01)00880304447158(17)200901(10)162260R, (01)00880304447158(17)290206(10)386330, (01)00880304447158(17)290206(10)386300, (01)00880304447158(17)290421(10)399990, (01)00880304447158(17)290421(10)417210, (01)00880304447158(17)290422(10)417220, (01)00880304447158(17)290430(10)337710, (01)00880304447158(17)271127(10)118030R, (01)00880304447158(17)270825(10)732050R 732050R.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1656-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1638-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1639-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1640-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1641-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1642-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1643-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1644-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1645-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1646-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1647-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1648-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1649-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1650-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1651-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1652-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1653-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1654-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1655-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1656-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1657-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1658-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1659-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1660-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1661-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1662-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1663-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1664-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1665-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1666-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1667-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1668-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1669-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03
Z-1670-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-15	2020-04-03

Product code KWY

K052990Class IIStageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement StemBiomet, Inc. / cleared 2005-12-16

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)