Reported Jan 15, 2014 · Terminated
Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO…
The Anspach Effort, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Anspach Effort, Inc. · 4500 Riverside Drive · Palm Beach Gardens, FL · 33410-4235
Is this the product you have?
- Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD - 0.8MM DIAMOND BALL, 5.6CM, MCA5-15SB - 1.5MM FLUTED BALL, 5.6CM, MCA5-15SD - 1.5MM DIAMOND BALL, 5.6CM, MCA5-1SB - lMM FLUTED BALL, 5.6CM, MCA5-1SD - lMM DIAMOND BALL, 5.6CM, MCA5-2SB - 2MM FLUTED BALL, 5.6CM, MCA5-2SD - 2MM DIAMOND BALL, 5.6CM, MCA7-05SD - 0.5MM DIAMOND BALL, 7.3CM, MCA7-06SD - 0.6MM DIAMOND BALL, 7 .3CM, MCA7-07SD - 0.7MM DIAMOND BALL, 7.3CM, MCA7-08SD - 0.8MM DIAMOND BALL, 7.3CM, MCA7-15SB - 1.5MM FLUTED BALL, 7.3CM, MCA7-15SD 1.5MM DIAMOND BALL, 7.3CM, MCA7-1SB - lMM FLUTED BALL, 7.3CM, MCA7-1SD - 1 MM DIAMOND BALL, 7 .3CM, MCA7-2SB - 2MM FLUTED BALL, 7.3CM and MCA7-2SD - 2MM DIAMOND BALL, 7.3CM. The MCA attachment is a reusable device used with dissection tools. Dissection tools are single use, disposable cutter designed for cutting and shaping delicate bone, primary in otology procedures for delicate bone cutting.
- Lot codes and dates
All Lots for MCA - MICRO CURVED ATTACHMENTMCA5-05SD - 0.5MM DIAMOND BALL5.6CMMCA5-06SD - 0.6MM DIAMOND BALL5.6CMMCA5-07SD - 0.7MM DIAMOND BALL5.6CMMCA5-08SD - 0.8MM DIAMOND BALL5.6CMMCA5-15SB - 1.5MM FLUTED BALL5.6CMMCA5-15SD - 1.5MM DIAMOND BALL5.6CMMCA5-1SB - lMM FLUTED BALL5.6CMMCA5-1SD - lMM DIAMOND BALL5.6CMMCA5-2SB - 2MM FLUTED BALL5.6CMMCA5-2SD - 2MM DIAMOND BALL5.6CMMCA7-05SD - 0.5MM DIAMOND BALL7.3CMMCA7-06SD - 0.6MM DIAMOND BALL7 .3CMMCA7-07SD - 0.7MM DIAMOND BALL7.3CMMCA7-08SD - 0.8MM DIAMOND BALL7.3CMMCA7-15SB - 1.5MM FLUTED BALL7.3CMMCA7-15SD 1.5MM DIAMOND BALL7.3CMMCA7-1SB - lMM FLUTED BALL7.3CMMCA7-1SD - 1 MM DIAMOND BALL7 .3CMMCA7-2SB - 2MM FLUTED BALL7.3CM and MCA7-2SD - 2MM DIAMOND BALL7.3CM
- Amount recalled
- 6,824 imits (4,7324 in USA / 2,100 Foreign)
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in delicate bone in otologic procedures such as cochleostomy. The use of the device in dense bone removal may result in cu
This product could cause temporary or reversible health problems — stop using it.
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