Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 20, 2016
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Synthes (USA) Products LLC recalled SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Subst… - a moderate-severity action.
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Subst… was recalled by Synthes (USA) Products LLC in April 20, 2016. Reason: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantatio…. Check the official notice for the remedy. Verify recall #Z-1385-2016 with the FDA Devices before acting.
The recall
Synthes (USA) Products LLC issued this moderate-severity FDA Devices recall-It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantatio….
- Moderate
- severity level
- 289 units
- affected scope
- Class II
- classification
- April 20, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1385-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1385-2016) was formally reported on April 20, 2016, with the manufacturer initiating the action on December 8, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Synthes (USA) Products LLC is listed as the recalling firm, operating out of West Chester, PA. Federal records list the affected scope as 289 units.
The documented reason for this recall is: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subseq… Distribution data in the federal record shows the product reached: Nationwide: NY, PA, AL, WI, FL, MO, TN, OH, MI, MN, CO, CA, NV, AZ, LA, OR, TX, IA, IN, MS, IL, AR, WV, HI, VA, MD, WA, OK, MA, KY, NJ, CT, No foreign accounts.. 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
289 units
Related Recalls
6
3 from same agency
Product description
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
Reason for recall
It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a SYNTHECEL implant. SYNTHECEL Dura Repair labeling and promotional material are being updated to clarify that SYNTHECEL is intended to remain in place and is not intended to be removed.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1385-2016 |
| Date reported | April 20, 2016 |
| Date initiated | December 8, 2015 |
| Recalling firm | Synthes (USA) Products LLC |
| Firm location | West Chester, PA |
| Affected scope | 289 units |
| Distribution | Nationwide: NY, PA, AL, WI, FL, MO, TN, OH, MI, MN, CO, CA, NV, AZ, LA, OR, TX, IA, IN, MS, IL, AR, WV, HI, VA, MD, WA, OK, MA, KY, NJ, CT, No foreign accounts. |
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-1385-2016) 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? ▼
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.. Recalled by Synthes (USA) Products LLC. Units affected: 289 units.
Why was this product recalled? ▼
It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a SYNTHECEL implant. SYNTHECEL Dura Repair labeling and promotional material are being updated to clarify that SYNTHECEL is intended to remain in place and is not intended to be removed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 20, 2016. Severity: Moderate. Recall number: Z-1385-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide: NY, PA, AL, WI, FL, MO, TN, OH, MI, MN, CO, CA, NV, AZ, LA, OR, TX, IA, IN, MS, IL, AR, WV, HI, VA, MD, WA, OK, MA, KY, NJ, CT, No foreign accounts..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1385-2016) 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 April 20, 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.