Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 29, 2019
Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem¿ is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid i
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Collagen Matrix, Inc. recalled Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Pro… - a moderate-severity action.
Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Pro… was recalled by Collagen Matrix, Inc. in May 29, 2019. Reason: Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem …. Check the official notice for the remedy. Verify recall #Z-1389-2019 with the FDA Devices before acting.
The recall
Collagen Matrix, Inc. issued this moderate-severity FDA Devices recall-Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem ….
- Moderate
- severity level
- 45 units
- affected scope
- Class II
- classification
- May 29, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1389-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1389-2019) was formally reported on May 29, 2019, with the manufacturer initiating the action on March 19, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Collagen Matrix, Inc. is listed as the recalling firm, operating out of Allendale, NJ. Federal records list the affected scope as 45 units -US;170 units OUS.
The documented reason for this recall is: Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box Distribution data in the federal record shows the product reached: Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.. 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
45 units -US;170 units OUS
Related Recalls
6
3 from same agency
Product description
Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem¿ is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.
Reason for recall
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1389-2019 |
| Date reported | May 29, 2019 |
| Date initiated | March 19, 2019 |
| Recalling firm | Collagen Matrix, Inc. |
| Firm location | Allendale, NJ |
| Affected scope | 45 units -US;170 units OUS |
| Distribution | Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel. |
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-1389-2019) 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? ▼
Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem¿ is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.. Recalled by Collagen Matrix, Inc.. Units affected: 45 units -US;170 units OUS.
Why was this product recalled? ▼
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2019. Severity: Moderate. Recall number: Z-1389-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1389-2019) 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 May 29, 2019. 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.