Z-1248-2018Class II

Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number...

Name: Z-1248-2018 Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2017-11-09
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2017-11-09 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use on 2017-11-09. FDA classified it as Class II and gives the reason as "Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates". 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-1248-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-09
Posted: 2018-03-28
Terminated: 2019-04-16
Recalling firm: Stryker Corp.
Product: Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
Product code: JDZ Mixer, Cement, For Clinical Use
Reason for recall: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: Letters dated November 16, 2017, were sent to customers. Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine if any devices from the affected lots are at your facility. 3. Quarantine and discontinue use of the recalled devices. 4. Complete and sign the enclosed Business Reply Form (BRF). 5. If you have further distributed these products, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF. 6. Return the completed BRF to Stryker Instruments Post Market Regulatory Compliance via fax (866-521- 2762) or email ([email protected]). 7. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. 8. Report any adverse events associated with the use of these devices to Stryker Instruments 1-800-253-3210, including any infections potentially associated with the use of affected product.
Quantity in commerce: 1542
Distribution: Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
Product codes and lots: Lot Numbers: 17282012, 17283012, 17297012, 17298012 UDI: (01)4546540055415

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1248-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1243-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1244-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1245-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1246-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1247-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1248-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1249-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1250-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1251-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1252-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1253-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1254-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28
Z-1255-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28

Product code JDZ

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