Z-2876-2018Class II

Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35

Name: Z-2876-2018 Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35
Creator: Zimmer Biomet, Inc.
Published: 2018-06-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-06-22 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures on 2018-06-22. FDA classified it as Class II and gives the reason as "The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cause a delay in surgery of less...". 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-2876-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-22
Posted: 2018-08-18
Terminated: 2019-10-09
Recalling firm: Zimmer GmbH
Product: Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cause a delay in surgery of less than 30 minutes. There is an option in the surgical technique for performing limb alignment without the alignment tower.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On June 22, 2018, the firm distributed Urgent Medical Device Recall letters to distributors and hospital risk managers. Actions for Risk Managers: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. Actions for Distributors: 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. 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. Include a copy of Attachment 2 Certificate of Sterilization with returned instruments. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to [email protected]. a. Review the list of hospitals included with the email notification sent to your facility, which includes a list of hospitals that have already been notified of this recall. b. Identify whether there are any additional hospitals that Zimmer Biomet has not notified and list these
Quantity in commerce: 385
Distribution: Worldwide Distribution - Nationwide distribution and the countries of Japan and Netherlands.
Product codes and lots: 63465803, 63762260, 63767434, 63799794

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2876-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2876-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-18

Product code LXH

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