Zimmer Biomet, Inc.: Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies

Recall number

Z-1114-2017

Recalling firm

Zimmer Biomet, Inc.

Product

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

Status

Terminated

Initiated

2016-12-16

Posted

2017-01-28

Terminated

2017-07-21

Reason

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

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 corporatequality.postmarket@zimmerbiomet.com 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 rgarequest@zimmerbiomet.com. Be sure to specify RECALL as the RGA type. b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com. 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

16

Distribution

WI NJ CA MD WA LA MA TX

Lot, serial or model codes

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

510(k) numbers

["K083827"]

PMA numbers

not on file

Product code

KRO

Firm FEI

1825034

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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