Z-1114-2017Class II

Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee...

Name: Z-1114-2017 Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee...
Creator: Zimmer Biomet, Inc.
Published: 2016-12-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-12-16 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies on 2016-12-16. FDA classified it as Class II and gives the reason as "labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1114-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-16
Posted: 2017-01-28
Terminated: 2017-07-21
Recalling firm: Zimmer GmbH
Product: Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On 12/16/2016 and 12/21/2016, Zimmer Biomet contacted distributors via telephone to notify them of the issue and requested that the product be placed in a quarantine location to prevent use. On 12/22/2016 URGENT MEDICAL DEVICE RECALL REMOVAL- LOT SPECIFIC notifications were sent to the affected distributors and Risk Managers / Surgeons via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Distributor responsibilities include: 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 and surgeons within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet. a. Request a Return Authorization Number via email to [email protected]. Be sure to specify RECALL as the RGA type. b. For each return, send a copy of Attachment 1 to [email protected]. c. Include a hardcopy of Attachment 1 with your shipment for immediate processing. 5. Note that any hospitals and/or surgeons that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager and Surgeon Recall Notice directly. It is important that you review the list of hospitals and/or surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for a
Quantity in commerce: 16
Distribution: WI NJ CA MD WA LA MA TX
Product codes and lots: Part # Lot # UDI CP113462 646200 (01) 0 0880304 51008 1 (17) 250928 (10) 646200 CP113462 690040 (01) 0 0880304 51008 1 (17) 260714 (10) 690040 CP113462 003620 (01) 0 0880304 51008 1 (17) 260324 (10) 003620 CP113462 498380 (01) 0 0880304 51008 1 (17) 250929 (10) 498380 CP113462 690050 (01) 0 0880304 51008 1 (17) 260622 (10) 690050 CP113462 539760 (01) 0 0880304 51008 1 (17) 251007 (10) 539760 CP113462 409190 (01) 0 0880304 51008 1 (17) 260417 (10) 409190 CP113462 799300 (01) 0 0880304 51008 1 (17) 260802 (10) 799300 CP113462 460990 (01) 0 0880304 51008 1 (17) 260416 (10) 460990

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1114-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1114-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-01-28

Product code KRO

K083827Class IIOrthopedic Salvage System (Oss) 9Cm Cobalt - Chrome Tibial BodiesBiomet Manufacturing Corp / cleared 2009-02-13

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)