Z-0956-2017Class II

Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into...

Name: Z-0956-2017 Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into...
Creator: Zimmer Biomet, Inc.
Published: 2016-12-06
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-12-06 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of 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... on 2016-12-06. FDA classified it as Class II and gives the reason as "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...". 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-0956-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-06
Posted: 2017-01-06
Terminated: 2017-06-01
Recalling firm: Zimmer GmbH
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
Product code: HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected]. 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 [email protected] . Be sure to specify RECALL as the RGA type. b. For each return, send a copy of Inventory Return Certifictaion Form via email to [email protected]. 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 [email protected]. Customer Service Zimmer Biomet, Inc. P.O. Box 708 Warsaw, I
Quantity in commerce: 12 units distributed
Distribution: Domestic: None Froeign: Netherlands & Switzerland VA/DOD: None
Product codes and lots: Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Date of Mfg. 26 Apr 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0956-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0956-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-06

Product code HRY

K133940Class IIOxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd. / cleared 2014-03-28

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)