Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 17, 2016
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is
Incorrect drill protocol in the Instructions for Use (IFU)
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Nobel Biocare Usa Llc recalled Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Us… - a moderate-severity action.
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Us… was recalled by Nobel Biocare Usa Llc in August 17, 2016. Reason: Incorrect drill protocol in the Instructions for Use (IFU). Check the official notice for the remedy. Verify recall #Z-2375-2016 with the FDA Devices before acting.
The recall
Nobel Biocare Usa Llc issued this moderate-severity FDA Devices recall-Incorrect drill protocol in the Instructions for Use (IFU).
- Moderate
- severity level
- Class II
- classification
- August 17, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2375-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2375-2016) was formally reported on August 17, 2016, with the manufacturer initiating the action on July 20, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Nobel Biocare Usa Llc is listed as the recalling firm, operating out of Yorba Linda, CA. Federal records list the affected scope as 231 kits.
The documented reason for this recall is: Incorrect drill protocol in the Instructions for Use (IFU) Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.. 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
231 kits
Related Recalls
6
3 from same agency
Product description
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.
Reason for recall
Incorrect drill protocol in the Instructions for Use (IFU)
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2375-2016 |
| Date reported | August 17, 2016 |
| Date initiated | July 20, 2016 |
| Recalling firm | Nobel Biocare Usa Llc |
| Firm location | Yorba Linda, CA |
| Affected scope | 231 kits |
| Distribution | Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey. |
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-2375-2016) 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? ▼
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.. Recalled by Nobel Biocare Usa Llc. Units affected: 231 kits.
Why was this product recalled? ▼
Incorrect drill protocol in the Instructions for Use (IFU)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 17, 2016. Severity: Moderate. Recall number: Z-2375-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2375-2016) 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 August 17, 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.