***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The… — Class II medical device recall Z-0654-2014
Terminated recall by The Anspach Effort, Inc., reported 2014-01-15, distributed nationwide. The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System,
| Recall number | Z-0654-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Anspach Effort, Inc., Palm Beach Gardens, FL, United States |
| Recall initiated | 2013-04-25 |
| Classified | 2014-01-09 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2015-07-20 |
| Distributed | Nationwide (US) |
| Quantity | 2,785 |
| Serial numbers | 31496602 |
Product
***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.
Reason for recall
The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0654-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.