Z-1240-2018Class II

Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery

Name: Z-1240-2018 Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
Creator: Zimmer Biomet, Inc.
Published: 2017-10-24
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-10-24 / Terminated / root cause: design

FDA source

Zimmer Biomet, Inc. began a recall of Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery on 2017-10-24. FDA classified it as Class II and gives the reason as "Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the potential to feel tight during...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1240-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-24
Posted: 2018-03-28
Terminated: 2019-04-03
Recalling firm: Zimmer GmbH
Product: Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Zimmer Biomet is conducting a medical device recall for the Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. Complaints received indicated that flexion has the potential to feel tight during range-of-motion trialing and that the final trial has the potential to appear looser in extension.
Root cause tag: design
FDA root cause: Component design/selection
Action: The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/31/2017 to customers titled "Affected Product: Persona Partial Knee Spacer Blocks Size 8mm, 9mm, 10mm, 12mm, 14mm". The letter described the product, problem, and actions to be taken. The letter instructed customers to review the notification and ensure that affected personnel are aware of the contents. Review inventory for affected product which would then be quarantined and ultimately removed by a firm sales representative. The customers were also instructed to complete and return the Certificate of Acknowledgement Form (even if you do not have affected products at your facility) via email to: [email protected] or Fax to: 574-372-4265. 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 transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 430
Distribution: US Nationwide Distribution.
Product codes and lots: 42-5399-035-08/09/10/12/14 (Sizes 8mm, 9mm, 10mm, 12mm, 14mm) Lot numbers: 63552644 63579568 63547276 63579569 63610265 63549084 63579674 63594433 63610266 63549096 63579676 63594434 63610267 63549097 63579680 63596547 63613101

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1240-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1240-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28

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)