Zimmer Biomet, Inc.: Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier. The pouch is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The pouch and carton labels also contain sterilization indicator dots. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement. The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement

Recall number

Z-0956-2017

Recalling firm

Zimmer Biomet, Inc.

Product

Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This pouch acts as the sterile barrier. The pouch is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The pouch and carton labels also contain sterilization indicator dots. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement. The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement

Status

Terminated

Initiated

2016-12-06

Posted

2017-01-06

Terminated

2017-06-01

Reason

Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zimmer Biomet received product complaints reporting that when the package labeled as a Right was opened it actually contained a Left Bearing.

Root cause

Employee error

Action

Zimmer Biomet sent an Urgent Medical Device Recall letter dated December 6, 2016. to all affected customers for a single lot of Oxford Fixed Lateral Bearings via e-mailed letter. Zimmer Biomet received two product complaints reporting that when the package labeled as a Right was opened it actually contained a Left Bearing. Risks: If another bearing is not available, a delay greater than 30 minutes may occur. If the product of the incorrect orientation is implanted, premature revision may be required. Customers were instructed to review the recall 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 the Inventory Return Certification Form a. Return a digital copy within three (3) days via email to corporatequality.postmarket@zimmerbiomet.com. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Inventory Return Certification Form to Zimmer Biomet. Request a Return Authorization Number via email at rgarequest@zimmerbiomet.com . Be sure to specify RECALL as the RGA type. b. For each return, send a copy of Inventory Return Certifictaion Form via email to corporatequality.postmarket@zimmerbiomet.com. c. Include a hardcopy of Inventory Return Certifictaion Form to Zimmer Biomet with your shipment for immediate processing. d. Mark the outside of the returns box(es) clearly with RECALL. 5. If after reviewing this notice you have further questions or concerns please call 1-877-946-2761 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of business hours will receive a prompt to record a voicemail and will be returned upon receipt. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com. Customer Service Zimmer Biomet, Inc. P.O. Box 708 Warsaw, I

Quantity

12 units distributed

Distribution

Domestic: None Froeign: Netherlands & Switzerland VA/DOD: None

Lot, serial or model codes

Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Date of Mfg. 26 Apr 2015

510(k) numbers

["K133940"]

PMA numbers

not on file

Product code

HRY

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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