Product is Anspach eMax Drill System console, catalog… recallZ-1243-03 · The Anspach Effort, Inc. · initiated Apr 23, 2003
Terminated All recalls posted in October 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from The Anspach Effort, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Faulty component causing a malfunction which would unexpectedly shutdown the drill system and user may not be able to restart.
FDA root cause category: Other
What the company is doing
A recall notification letter was mailed to domestic consignees and faxed to international consignees on April 23, 2003. The letter requests return of the devices.
Recall details
- Recall number
- Z-1243-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 23, 2003
- Posted by the FDA
- Oct 15, 2003
- Recalling firm
- The Anspach Effort, Inc.
- Quantity
- 24
- Product code
- HBC
- FDA submissions
- K011444
- Distribution
- The devices were distributed to 12 domestic hosptials in FL, GA, NC, TX, CA, MA, MS as well as three international accounts in Taiwan, South Africa and Italy.
Product description
Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs)
Code information (models, lots, serial numbers)
Serial Numbers: 50139962-2, 50128299-4, 50139968-5, 50139963-5, 50116580-5, 50128299-5, 50139964-2, 50139962-1, 50139971-2, 50139968-1, 50139964-3, 50128295-2, 50139964-1, 50139968-2, 50139964-4, 50128299-3, 50116576-2, 50128299-2, 50139968-3, 50139963-2, , 50139968-4, 50139963-4, 114766-1,114766-2
Other devices under the same FDA submission
29 devices cleared under K011444 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA CRANI-ASynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 recall772 reports
- NA QD11Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE580 reports
- NA QD8Synthes GmbH · MOTOR, DRILL, ELECTRIC386 reports
- NA SHORTSynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE343 reports
- NA MEDIUMSynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE135 reports
- NA LONGSynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE130 reports
- NA CRANI-LSynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 recall77 reports
- NA CRANI-PSynthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 recall74 reports
- NA QD14Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE78 reports
- NA CRANI-A-RAnspach Effort, The · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 recall8 reports
- NA CRANI-A-01Anspach Effort, The · MOTOR, DRILL, ELECTRIC1 recall0 reports
- NA CRANI-L-RAnspach Effort, The · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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