Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 12, 2016
Vanguard 360 Revision Knee System Knee prostheses
The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zimmer Biomet, Inc. recalled Vanguard 360 Revision Knee System Knee prostheses - a moderate-severity action.
Vanguard 360 Revision Knee System Knee prostheses was recalled by Zimmer Biomet, Inc. in October 12, 2016. Reason: The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included i…. Check the official notice for the remedy. Verify recall #Z-0003-2017 with the FDA Devices before acting.
The recall
Zimmer Biomet, Inc. issued this moderate-severity FDA Devices recall-The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included i….
- Moderate
- severity level
- 454 units
- affected scope
- Class II
- classification
- October 12, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0003-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0003-2017) was formally reported on October 12, 2016, with the manufacturer initiating the action on August 8, 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 454.
The documented reason for this recall is: The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result,… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Distribution to the states of : VA, UT, TX. OR, MN, AL, PA, CA and KY., and to the countries of : AUSTRALIA, China, Italy, Netherlands and Japan.. 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
454
Related Recalls
6
3 from same agency
Product description
Vanguard 360 Revision Knee System Knee prostheses
Reason for recall
The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. Therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened. The bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. This possible event can result in an intraoperative delay resulting in increased time under anesthesia.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0003-2017 |
| Date reported | October 12, 2016 |
| Date initiated | August 8, 2016 |
| Recalling firm | Zimmer Biomet, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 454 |
| Distribution | Worldwide Distribution - US Distribution to the states of : VA, UT, TX. OR, MN, AL, PA, CA and KY., and to the countries of : AUSTRALIA, China, Italy, Netherlands and Japan. |
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-0003-2017) 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? ▼
Vanguard 360 Revision Knee System Knee prostheses. Recalled by Zimmer Biomet, Inc.. Units affected: 454.
Why was this product recalled? ▼
The drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. Therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened. The bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. This possible event can result in an intraoperative delay resulting in increased time under anesthesia.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 12, 2016. Severity: Moderate. Recall number: Z-0003-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Distribution to the states of : VA, UT, TX. OR, MN, AL, PA, CA and KY., and to the countries of : AUSTRALIA, China, Italy, Netherlands and Japan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0003-2017) 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 October 12, 2016. 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.