510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,544 records, page 558 of 1191
FDA device recalls, page 558 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1992-2017Class IICompact Speed Reducer, 60:1The Anspach Effort, Inc.BWN
Z-1991-2017Class IIPediatric CraniotomeThe Anspach Effort, Inc.BWN
Z-1990-2017Class IIRotating Large CraniotomeThe Anspach Effort, Inc.BWN
Z-1989-2017Class IILarge Craniotome Product Usage: Pneumatic systemThe Anspach Effort, Inc.BWN
Z-1988-2017Class IIRotating Adult Craniotome Product Usage: Pneumatic systemThe Anspach Effort, Inc.BWN
Z-1987-2017Class II6.5CM ADLT CRANI, THIN FT PLATE Product Usage: Pneumatic systemThe Anspach Effort, Inc.BWN
Z-1986-2017Class IIAdult Craniotome Product Usage: Pneumatic systemThe Anspach Effort, Inc.BWN
Z-1985-2017Class II6.8cm Controlled Depth Attachment Product Usage: Pneumatic systemThe Anspach Effort, Inc.BWN
Z-1984-2017Class II8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic systemThe Anspach Effort, Inc.BWN
Z-1983-2017Class IIPEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic systemThe Anspach Effort, Inc.BWN
Z-1982-2017Class II5.9CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic systemThe Anspach Effort, Inc.BWN
Z-1981-2017Class II12.6CM TAPERED ATTACHMENT, BLACK MAX Product Usage: Pneumatic systemThe Anspach Effort, Inc.BWN
Z-1980-2017Class II6.1CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic systemThe Anspach Effort, Inc.BWN
Z-1979-2017Class IIB-SAGITTAL ASSEMBLY Product Usage: Pneumatic systemThe Anspach Effort, Inc.BWN
Z-1978-2017Class II26.65Cm Attachment, Black MaxThe Anspach Effort, Inc.BWN
Z-1977-2017Class II7.5Cm Angle Attachment, Black MaxThe Anspach Effort, Inc.BWN
Z-1976-2017Class II8Cm Angle Attachment, Black MaxThe Anspach Effort, Inc.BWN
Z-1975-2017Class II13.5Cm Angle Attachment, Black MaxThe Anspach Effort, Inc.BWN
Z-1974-2017Class II14Cm Angle Attachment, Black MaxThe Anspach Effort, Inc.BWN
Z-1973-2017Class II10.5Cm Angle Attachment, Black MaxThe Anspach Effort, Inc.BWN
Z-1972-2017Class II11Cm Angle Attachment, Black MaxThe Anspach Effort, Inc.BWN
Z-1971-2017Class II90 Deg Right Angle Attach, Black MaxThe Anspach Effort, Inc.BWN
Z-1970-2017Class IIContra Angle Attachment, Black MaxThe Anspach Effort, Inc.BWN
Z-1969-2017Class II9.4Cm Micro Revision Attach, Black MaxThe Anspach Effort, Inc.BWN
Z-1968-2017Class II16.5Cm Micro Revision Attach, Black MaxThe Anspach Effort, Inc.BWN
Z-1967-2017Class II22Cm Micro Revision Attach, Black MaxThe Anspach Effort, Inc.BWN
Z-1966-2017Class IIKeyless Driver, Black MaxThe Anspach Effort, Inc.BWN
Z-1965-2017Class II16Cm Min Invasive Attach, Black MaxThe Anspach Effort, Inc.BWN
Z-1964-2017Class IIAdjustable Drill Guide, Black MaxThe Anspach Effort, Inc.BWN
Z-1963-2017Class IIGreen Rotating Craniotome, Black MaxThe Anspach Effort, Inc.BWN
Z-1962-2017Class IIStandard Craniotome, Black MaxThe Anspach Effort, Inc.BWN
Z-1961-2017Class IILarge Craniotome, Black MaxThe Anspach Effort, Inc.BWN
Z-1960-2017Class II11.25Cm Attachment, Black MaxThe Anspach Effort, Inc.BWN
Z-1959-2017Class II19Cm Attachment, Black MaxThe Anspach Effort, Inc.BWN
Z-1958-2017Class II7.2cm Adjustable Drill Guide Product Usage: Electric systemThe Anspach Effort, Inc.BWN
Z-1957-2017Class IISystem Console, Single Port, no irrigationThe Anspach Effort, Inc.GET
Z-1956-2017Class IISystem Console, Single Port, with irrigation Product Usage: Electric systemThe Anspach Effort, Inc.GEY
Z-1955-2017Class IIConsole, eMax2 Plus Product Usage: Electric systemThe Anspach Effort, Inc.GEY
Z-1954-2017Class IIFoot Control without Switches, SC2100 Product Usage: Electric systemThe Anspach Effort, Inc.ERL
Z-1953-2017Class IIFoot Control, SC2100 Product Usage: Electric systemThe Anspach Effort, Inc.ERL
Z-1952-2017Class IIeMax2 PLUS Product Usage: Electric systemThe Anspach Effort, Inc.HBC
Z-1951-2017Class IIeMax2 Hybrid Hand Control Product Usage: Electric systemThe Anspach Effort, Inc.HBC
Z-1950-2017Class IIeMax2 Motor Assembly Product Usage: Electric systemThe Anspach Effort, Inc.HBC
Z-1949-2017Class IIElectronic Foot Control with Direction or Irrigation Switches Product Usage: Electric...The Anspach Effort, Inc.GEY
Z-1948-2017Class IIElectronic Foot Control with Direction Switch Product Usage: Electric systemThe Anspach Effort, Inc.GEY
Z-1947-2017Class IIElectric Handpiece EM Hand Control Product Usage: Electric systemThe Anspach Effort, Inc.HBC
Z-1946-2017Class IIElectronic Foot Control with Direction or Irrigation Switches Product Usage: Electric...The Anspach Effort, Inc.ERL
Z-1945-2017Class IIXMAX Motor, High Strength Hose Product Usage: Pneumatic systemThe Anspach Effort, Inc.ERL
Z-1944-2017Class IIXMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic systemThe Anspach Effort, Inc.ERL
Z-1943-2017Class IIIMRI MOTOR Product Usage: Pneumatic systemThe Anspach Effort, Inc.HBE