Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 25, 2020
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Merz North America, Inc. recalled COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spher… - a moderate-severity action.
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spher… was recalled by Merz North America, Inc. in November 25, 2020. Reason: The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.. Check the official notice for the remedy. Verify recall #Z-0401-2021 with the FDA Devices before acting.
The recall
Merz North America, Inc. issued this moderate-severity FDA Devices recall-The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study..
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- November 25, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0401-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0401-2021) was formally reported on November 25, 2020, with the manufacturer initiating the action on September 30, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Merz North America, Inc. is listed as the recalling firm, operating out of Franksville, WI. Federal records list the affected scope as 2051 units.
The documented reason for this recall is: The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study. Distribution data in the federal record shows the product reached: US only distribution - AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. 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
2051 units
Related Recalls
6
3 from same agency
Product description
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.
Reason for recall
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0401-2021 |
| Date reported | November 25, 2020 |
| Date initiated | September 30, 2020 |
| Recalling firm | Merz North America, Inc. |
| Firm location | Franksville, WI |
| Affected scope | 2051 units |
| Distribution | US only distribution - AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
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-0401-2021) 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? ▼
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.. Recalled by Merz North America, Inc.. Units affected: 2051 units.
Why was this product recalled? ▼
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2020. Severity: Moderate. Recall number: Z-0401-2021.
Where was the recalled product distributed? ▼
Distribution: US only distribution - AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0401-2021) 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 25, 2020. 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.