Z-2601-2023Class II

Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox...

Name: Z-2601-2023 Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox...
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, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant... 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-2601-2023
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, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-703-000
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: 16 units US;
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: 07613327051285 Lot Numbers: 23010012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2601-2023
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)