Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 18, 2017
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. P
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 packag…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zimmer Biomet, Inc. recalled Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The pr… - a moderate-severity action.
Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The pr… was recalled by Zimmer Biomet, Inc. in January 18, 2017. Reason: Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zi…. Check the official notice for the remedy. Verify recall #Z-0956-2017 with the FDA Devices before acting.
The recall
Zimmer Biomet, Inc. issued this moderate-severity FDA Devices recall-Zimmer Biomet is initiating a removal of a single lot of Oxford Fixed Lateral Bearings due to mislabeling. Zi….
- Moderate
- severity level
- 12 units
- affected scope
- Class II
- classification
- January 18, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0956-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0956-2017) was formally reported on January 18, 2017, with the manufacturer initiating the action on December 6, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer Biomet, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 12 units distributed.
The documented reason for this recall is: 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 act… Distribution data in the federal record shows the product reached: Domestic: None Froeign: Netherlands & Switzerland VA/DOD: None. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
12 units distributed
Related Recalls
6
3 from same agency
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0956-2017 |
| Date reported | January 18, 2017 |
| Date initiated | December 6, 2016 |
| Recalling firm | Zimmer Biomet, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 12 units distributed |
| Distribution | Domestic: None Froeign: Netherlands & Switzerland VA/DOD: None |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0956-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zimmer Biomet, Inc.. Units affected: 12 units distributed.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-0956-2017.
Where was the recalled product distributed? ▼
Distribution: Domestic: None Froeign: Netherlands & Switzerland VA/DOD: None.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0956-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 18, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.