Z-2234-2019Class II

Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813

Name: Z-2234-2019 Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
Creator: Zimmer Biomet, Inc.
Published: 2019-07-02
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-07-02 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813 on 2019-07-02. FDA classified it as Class II and gives the reason as "Cleaning processes potentially being ineffective". 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-2234-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-02
Posted: 2019-08-09
Terminated: 2021-09-10
Recalling firm: Zimmer GmbH
Product: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Cleaning processes potentially being ineffective
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Risk Manager Responsibilities: 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 Certificate of Acknowledgement and send to Corporate Quality. [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. 5. 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]. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Certificate of Acknowledgement and send to [email protected]. This form must be returned. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. 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 t
Quantity in commerce: 39
Distribution: Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands.
Product codes and lots: Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2234-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2231-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-09
Z-2232-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-09
Z-2233-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-09
Z-2234-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-09
Z-2235-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-09
Z-2236-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-09

Product code JDI

K142814Class IIBiomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC / cleared 2015-06-25

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)