Z-1522-2018Class II

Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600

Name: Z-1522-2018 Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600
Creator: Zimmer Biomet, Inc.
Published: 2018-04-03
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-04-03 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long... on 2018-04-03. FDA classified it as Class II and gives the reason as "There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar". 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-1522-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-03
Posted: 2018-04-25
Terminated: 2018-07-02
Recalling firm: Zimmer GmbH
Product: Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Zimmer Biomet sent an Urgent Medical Device Recall letters to their affected customers. The letters identified the affected product, problem and the actions to be taken. Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. For each return, complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. For each return, send a copy of Attachment 1 to [email protected]. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to [email protected]. a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeons that have already been notified of this recall. b. Identify whether there are any additional hospitals and/or surgeons that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts or surgeons to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. 5. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transf
Quantity in commerce: 16 units (21 distribution events. The product is lot controlled and may be distributed multiple times if it was returned and returned to the shelf)
Distribution: The product was distributed to the following states: CT, FL, GA, IN, MA, MI, NY, and TX. The product was distributed to the following countries: Malaysia and Netherlands.
Product codes and lots: Lot Number 360610, 333020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1522-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1522-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-25

Product code HSB

K042409Class IIModular Arthrodesis NailBiomet, Inc. / cleared 2004-12-02

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)