Z-2598-2023Class II

Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone...

Name: Z-2598-2023 Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone...
Creator: Stryker Corporation
Published: 2023-08-07
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2023-08-07 / Open, Classified

FDA source

Stryker Corporation began a recall of Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the... on 2023-08-07. FDA classified it as Class II and gives the reason as "Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2598-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-07
Posted: 2023-09-19
Recalling firm: Stryker Corp.
Product: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000
Product code: LZN Cement Obturator
Reason for recall: Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site
FDA root cause: Under Investigation by firm
Action: Stryker issued Urgent Medical Device Recall letter on 8/07/23. Letter states reason for recall, health risk and action to take: Actions needed 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if affected product is no longer in inventory, to the email [email protected]. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement order will be shipped to customers upon receipt of the recalled product. 5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. If you have any questions about this matter, contact Stryker Instruments by email at [email protected].
Quantity in commerce: 5155 units US; 1607 units OUS
Distribution: Nationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy Malaysia Poland Singapore South Korea Spain Taiwan Thailand UK
Product codes and lots: GTIN: 04546540055408 Lot Numbers: 22305012 22306012 22307012 22308012 22311012 22315012 22316012 22318012 22319012 22320012 22321012 22322012 22323012 22325012 22326012 22327012 22332012 22333012 22334012 22335012 22336012 22337012 22340012 22341012 22342012 22346012 22347012 22348012 22351012 22353012 22354012 22355012 22356012 22357012 22361012 22362012 22363012 22364012 23003012 23004012 23005012 23009012 23010012 23011012 23012012 23013012 23014012 23015012 23017012 23018012 23019012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2598-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2596-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-18
Z-2597-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-18
Z-2598-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-18
Z-2599-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-18
Z-2600-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-18
Z-2601-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-18
Z-2602-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-18

Product code LZN

K931847Class IIBio-Prep Cement RestrictorBiomedical Devices, Inc. / cleared 1994-06-28

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)