Z-1957-2017Class II
System Console, Single Port, no irrigation
The Anspach Effort, Inc. / initiated 2016-10-06 / Terminated
The Anspach Effort, Inc. began a recall of System Console, Single Port, no irrigation on . FDA classified it as Class II and gives the reason as "Supplied Directions for Use (DFU) did not contain a recommended service interval". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1957-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- The Anspach Effort, Inc.
- Product
- System Console, Single Port, no irrigation
- Product code
- GET Motor, Surgical Instrument, Pneumatic Powered
- Reason for recall
- Supplied Directions for Use (DFU) did not contain a recommended service interval.
- FDA root cause
- Under Investigation by firm
- Action
- 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 [email protected]. 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.
- Quantity in commerce
- 239
- Distribution
- Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
- Product codes and lots
- All product shipped prior to 09/27/2016; DFU 18-0085; Part No. SC2102.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1930-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1931-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1932-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1933-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1934-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1935-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1936-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1937-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1938-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1939-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1940-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1941-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1942-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1943-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1944-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1945-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1946-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1947-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1948-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1949-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1950-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1951-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1952-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1953-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1954-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1955-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1956-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1957-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1958-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1959-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1960-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1961-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1962-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1963-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1964-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1965-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1966-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1967-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1968-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1969-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1970-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1971-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1972-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1973-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1974-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1975-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1976-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1977-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1978-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1979-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1980-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1981-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1982-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1983-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1984-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1985-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1986-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1987-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1988-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1989-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1990-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1991-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1992-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1993-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1994-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1995-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1996-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1997-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1998-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1999-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2000-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2001-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2002-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2003-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2004-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2005-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2006-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2007-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2008-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2009-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2010-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2011-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2012-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2013-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2014-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2015-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2016-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2017-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2018-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2019-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2020-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2021-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2022-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2023-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2024-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2025-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2026-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2027-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2028-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2029-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2030-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2031-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2032-2017 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.