Z-1805-2018Class II

Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery...

Name: Z-1805-2018 Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery...
Creator: Zimmer Biomet, Inc.
Published: 2017-08-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-08-07 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis on 2017-08-07. FDA classified it as Class II and gives the reason as "There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1805-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-07
Posted: 2018-05-11
Terminated: 2018-08-23
Recalling firm: Zimmer GmbH
Product: Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
FDA root cause: Under Investigation by firm
Action: The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) LOT SPECIFIC" letter dated 8/7/17 to its Customers. The letter described the product, problem and actions to be taken. The Distributors were instructed to: 1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form a. Return a digital copy to [email protected] within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form and Attachment 3 Certificate of Decontamination to Zimmer Biomet. a. For each return, send a copy of Attachment 1 and Attachment 2 to [email protected]. b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Include a hardcopy of Attachment 2 with returned instruments. Mark the outside of the returned boxes clearly with RECALL. 5. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals that may have received or used the affected product. If there are no additional users to notify, please indicate that no additional users have been identified. 6. Retain a copy of your recall acknowledgement and product return forms for your records in the event of a compliance audit of your facility. 7. If after reviewing this notice you have further questions or concerns please call the customer call center at (574) 371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergen
Quantity in commerce: 842 products in total
Distribution: Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, SC, TX, UT, VA, WA, WI, and Puerto Rico; and to countries of: Australia, Canada, Hong Kong, India, Japan, Korea, Malaysia, Netherlands, and Singapore.
Product codes and lots: Lot 63535352, UDI (01)00889024246935(10)63607357; Lot 63535352, UDI (01)00889024246935(10)63535352

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1805-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1805-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-11
Z-1806-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-11
Z-1807-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-11
Z-1808-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-23	2018-05-11

Product code JWH

K113369Class IIZimmer Persona Knee SystemZimmer, Inc. / cleared 2012-03-27

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)