Food, drugs, devices › The Anspach Effort, Inc.
Device recall: AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile
The Anspach Effort, Inc. (Palm Beach Gardens, FL) initiated this device recall on 31 Mar 2011; FDA lists 2 product records under event 67176, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 114 device enforcement events initiated in 2011 carry the same class.
Status: Terminated, terminated 18 Jul 2019. Initiation: voluntary: firm initiated. The Anspach Effort, Inc. has 35 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
The Anspach Effort, Inc., Palm Beach Gardens, FL.
Reason for recall
"Cutter was longer than was stated on the label"
Distribution
"Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0829-2014 | AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs. | 599 cutting burs | Class II | Terminated | 5 Feb 2014 |
| Z-0830-2014 | Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs. | 29 cutting burs | Class II | Terminated | 5 Feb 2014 |
Context
Other enforcement events for The Anspach Effort, Inc.
All 35 events for The Anspach Effort, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Cutter was longer than was stated on the label"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Jul 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.