Recall Z-1947-2017
The Anspach Effort, Inc. · initiated October 6, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Electric Handpiece EM Hand Control Product Usage: Electric system
Codes / lots: All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-HC.
Reason for recall
Supplied Directions for Use (DFU) did not contain a recommended service interval.
FDA-determined cause: Under Investigation by firm
Action taken
Consignees were sent a recall notice via mail, dated 10/10/2016. In the notice, the firm notifies consignees of the Directions For Use (DFU) correction that will include recommended servicing intervals. All DFUs distributed after 09/28/2016 will have the correct DFU. The recalling firm instructs consignees to review the service intervals provided for product received, forward the notification to necessary parties and/or facilities, and complete the attached Verification Form. Complete Verification Forms are to be sent by fax to 877-546-5069 or by email to Anspach4870@stericycle.com. Consignees are also asked to maintain a copy of the notice for their records. Any questions can be directed to Customer Service at 1-800-327-6887, option 1.
Details
- Recall number
- Z-1947-2017
- Initiated
- October 6, 2016
- Terminated
- July 26, 2019
- Product code
- HBC – Motor, Drill, Electric
- Quantity
- 32
- Distribution
- Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
- Recalling firm
- The Anspach Effort, Inc., Palm Beach Gardens, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1930-2017 Class II | 14cm QD Angle Attachment Product Usage: Product attachmentSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1931-2017 Class II | AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1932-2017 Class II | AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1933-2017 Class II | Foot control irrigation system Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1934-2017 Class II | Autolube-III Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1935-2017 Class II | Autolube-III with 20ft hose Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1936-2017 Class II | AL-III-DISS Adapter Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1937-2017 Class II | Autolube-III with Foot Guard Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1938-2017 Class II | Autolube-III with Irrigation Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1939-2017 Class II | Autolube-III with NK Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1940-2017 Class II | 19cm Attachment, Black Max Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1941-2017 Class II | BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1942-2017 Class II | IMRI AIR CONTROL Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1943-2017 Class II | IMRI MOTOR Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1944-2017 Class II | XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1945-2017 Class II | XMAX Motor, High Strength Hose Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1946-2017 Class II | Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric…Supplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1948-2017 Class II | Electronic Foot Control with Direction Switch Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1949-2017 Class II | Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric…Supplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1950-2017 Class II | eMax2 Motor Assembly Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1951-2017 Class II | eMax2 Hybrid Hand Control Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1952-2017 Class II | eMax2 PLUS Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1953-2017 Class II | Foot Control, SC2100 Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1954-2017 Class II | Foot Control without Switches, SC2100 Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1955-2017 Class II | Console, eMax2 Plus Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1956-2017 Class II | System Console, Single Port, with irrigation Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1957-2017 Class II | System Console, Single Port, no irrigationSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1958-2017 Class II | 7.2cm Adjustable Drill Guide Product Usage: Electric systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1959-2017 Class II | 19CM ATTACHMENT, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |
| Z-1960-2017 Class II | 11.25CM ATTACHMENT, BLACK MAXSupplied Directions for Use (DFU) did not contain a recommended service interval. | 10/06/2016Terminated |