Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported November 21, 2018
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The o…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Collagen Matrix, Inc. recalled BioMend Extend, REF# 0142Z, Synthetic bone grafting material. - a low-severity action.
BioMend Extend, REF# 0142Z, Synthetic bone grafting material. was recalled by Collagen Matrix, Inc. in November 21, 2018. Reason: There is a possibility that the product was packaged in the wrong box. Specifically, the product may have be…. Check the official notice for the remedy. Verify recall #Z-0414-2019 with the FDA Devices before acting.
The recall
Collagen Matrix, Inc. issued this low-severity FDA Devices recall-There is a possibility that the product was packaged in the wrong box. Specifically, the product may have be….
- Low
- severity level
- 569 units
- affected scope
- Class III
- classification
- November 21, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0414-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0414-2019) was formally reported on November 21, 2018, with the manufacturer initiating the action on August 16, 2018. It is classified under Low severity (Class III), 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 569.
The documented reason for this recall is: There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is … Distribution data in the federal record shows the product reached: Distributed to one distributor located in Florida.. 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 - 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 - 40,422 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
569
Related Recalls
6
0 from same agency
Product description
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.
Reason for recall
There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0414-2019 |
| Date reported | November 21, 2018 |
| Date initiated | August 16, 2018 |
| Recalling firm | Collagen Matrix, Inc. |
| Firm location | Allendale, NJ |
| Affected scope | 569 |
| Distribution | Distributed to one distributor located in Florida. |
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-0414-2019) 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? ▼
BioMend Extend, REF# 0142Z, Synthetic bone grafting material.. Recalled by Collagen Matrix, Inc.. Units affected: 569.
Why was this product recalled? ▼
There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 21, 2018. Severity: Low. Recall number: Z-0414-2019.
Where was the recalled product distributed? ▼
Distribution: Distributed to one distributor located in Florida..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0414-2019) 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 November 21, 2018. 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.