Severity
Moderate
FDA Devices recall · Reported February 5, 2014
Cutter was longer than was stated on the label
The Anspach Effort, Inc. recalled Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile… - a moderate-severity action.
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile… was recalled by The Anspach Effort, Inc. in February 5, 2014. Reason: Cutter was longer than was stated on the label. Check the official notice for the remedy. Verify recall #Z-0830-2014 with the FDA Devices before acting.
The recall
The Anspach Effort, Inc. issued this moderate-severity FDA Devices recall-Cutter was longer than was stated on the label.
Sourced from official FDA Devices enforcement records. Verify recall #Z-0830-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0830-2014) was formally reported on February 5, 2014, with the manufacturer initiating the action on March 31, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. The Anspach Effort, Inc. is listed as the recalling firm, operating out of Palm Beach Gardens, FL. Federal records list the affected scope as 29 cutting burs.
The documented reason for this recall is: Cutter was longer than was stated on the label Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.. 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.
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.
Severity
Moderate
Affected scope
29 cutting burs
Related Recalls
6
3 from same agency
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
Cutter was longer than was stated on the label
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0830-2014 |
| Date reported | February 5, 2014 |
| Date initiated | March 31, 2011 |
| Recalling firm | The Anspach Effort, Inc. |
| Firm location | Palm Beach Gardens, FL |
| Affected scope | 29 cutting burs |
| Distribution | Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany. |
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.
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.
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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 February 5, 2014. 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.