Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 15, 2018
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
New Era Orthopaedics, LLc recalled Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07 - a moderate-severity action.
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07 was recalled by New Era Orthopaedics, LLc in August 15, 2018. Reason: This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle S…. Check the official notice for the remedy. Verify recall #Z-2604-2018 with the FDA Devices before acting.
The recall
New Era Orthopaedics, LLc issued this moderate-severity FDA Devices recall-This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle S….
- Moderate
- severity level
- Class II
- classification
- August 15, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2604-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2604-2018) was formally reported on August 15, 2018, with the manufacturer initiating the action on February 13, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. New Era Orthopaedics, LLc is listed as the recalling firm, operating out of Hummelstown, PA. Federal records list the affected scope as 6 pieces.
The documented reason for this recall is: This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were applied to the sha… Distribution data in the federal record shows the product reached: 2 distributors in CO and TX.. 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 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
6 pieces
Related Recalls
6
0 from same agency
Product description
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07
Reason for recall
This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were applied to the shank insertion instrument and the laser weld failed.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2604-2018 |
| Date reported | August 15, 2018 |
| Date initiated | February 13, 2017 |
| Recalling firm | New Era Orthopaedics, LLc |
| Firm location | Hummelstown, PA |
| Affected scope | 6 pieces |
| Distribution | 2 distributors in CO and TX. |
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-2604-2018) 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? ▼
Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07. Recalled by New Era Orthopaedics, LLc. Units affected: 6 pieces.
Why was this product recalled? ▼
This is a retrospective recall of an instrument used in spine fusion procedures with Modera Modular Pedicle Screw system implants. The firm received a customer complaint in which excessive forces were applied to the shank insertion instrument and the laser weld failed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 15, 2018. Severity: Moderate. Recall number: Z-2604-2018.
Where was the recalled product distributed? ▼
Distribution: 2 distributors in CO and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2604-2018) 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 August 15, 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.