Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 27, 2016
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.
Incorrect top label on an implant package.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Nobel Biocare Usa Llc recalled Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered impla… - a moderate-severity action.
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered impla… was recalled by Nobel Biocare Usa Llc in July 27, 2016. Reason: Incorrect top label on an implant package.. Check the official notice for the remedy. Verify recall #Z-2237-2016 with the FDA Devices before acting.
The recall
Nobel Biocare Usa Llc issued this moderate-severity FDA Devices recall-Incorrect top label on an implant package..
- Moderate
- severity level
- 53 units
- affected scope
- Class II
- classification
- July 27, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2237-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2237-2016) was formally reported on July 27, 2016, with the manufacturer initiating the action on June 22, 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 53 units total (33 units in US).
The documented reason for this recall is: Incorrect top label on an implant package. Distribution data in the federal record shows the product reached: Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC. 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
53 units total (33 units in US)
Related Recalls
6
3 from same agency
Product description
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.
Reason for recall
Incorrect top label on an implant package.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2237-2016 |
| Date reported | July 27, 2016 |
| Date initiated | June 22, 2016 |
| Recalling firm | Nobel Biocare Usa Llc |
| Firm location | Yorba Linda, CA |
| Affected scope | 53 units total (33 units in US) |
| Distribution | Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC |
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-2237-2016) 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? ▼
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.. Recalled by Nobel Biocare Usa Llc. Units affected: 53 units total (33 units in US).
Why was this product recalled? ▼
Incorrect top label on an implant package.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2016. Severity: Moderate. Recall number: Z-2237-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2237-2016) 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 July 27, 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.