Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 11, 2017
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require
Endotoxin values from testing of retains slightly exceeded the established specification.
Tepha Incorporated recalled GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use… - a moderate-severity action.
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use… was recalled by Tepha Incorporated in January 11, 2017. Reason: Endotoxin values from testing of retains slightly exceeded the established specification.. Check the official notice for the remedy. Verify recall #Z-0948-2017 with the FDA Devices before acting.
The recall
Tepha Incorporated issued this moderate-severity FDA Devices recall-Endotoxin values from testing of retains slightly exceeded the established specification..
- Moderate
- severity level
- 29 units
- affected scope
- Class II
- classification
- January 11, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0948-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0948-2017) was formally reported on January 11, 2017, with the manufacturer initiating the action on November 21, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Tepha Incorporated is listed as the recalling firm, operating out of Lexington, MA. Federal records list the affected scope as 29.
The documented reason for this recall is: Endotoxin values from testing of retains slightly exceeded the established specification. Distribution data in the federal record shows the product reached: Nationwide Distribution to IN, CA, FL, MI, NV, and MT. 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
29
Related Recalls
6
3 from same agency
Product description
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Reason for recall
Endotoxin values from testing of retains slightly exceeded the established specification.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0948-2017 |
| Date reported | January 11, 2017 |
| Date initiated | November 21, 2016 |
| Recalling firm | Tepha Incorporated |
| Firm location | Lexington, MA |
| Affected scope | 29 |
| Distribution | Nationwide Distribution to IN, CA, FL, MI, NV, and MT |
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-0948-2017) 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? ▼
GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaSHAPE" 3D is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.. Recalled by Tepha Incorporated. Units affected: 29.
Why was this product recalled? ▼
Endotoxin values from testing of retains slightly exceeded the established specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 11, 2017. Severity: Moderate. Recall number: Z-0948-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution to IN, CA, FL, MI, NV, and MT.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0948-2017) 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 January 11, 2017. 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.