AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal C...
FDA Recall #Z-2548-2018 — Class II — April 28, 2010
Product Description
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
Reason for Recall
A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.
Recalling Firm
Cayenne Medical Inc. — Scottsdale, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,444 units total
Distribution
Worldwide distribution. US nationwide, Denmark, Finland, Malaysia, Netherlands, Poland, Switzerland, and Turkey.
Code Information
a. Model Number CM-7109, Lot Codes: 2091004, 3041001, 3151117, 3250806, 3291018, 4191101, 5181012, 6211011, 6270801, 7081012, 7131004, 7231005, 7281004, 7281019, 8161104, 8311131, 8311133, 8311134, 9081004, 9091102, 9141012, 9170902, 9220903, 9220910, 9271002, 10130801, 10140904, 10160901, 10211013, 11091001, 11161022, 11171022, 12030901, 12131001, 12281001, 12290910, 12291008, LNR; b. Model Number CM-7110, Lot Codes: 2091005, 3151118, 3250807, 3291014, 4191102, 4201002, 5181002, 5181009, 6211013, 6270802, 7081013, 7131005, 7231001, 7281005, 7281020, 7311217, 9030903, 9080802, 9081005, 9091103, 9141013, 9161103, 9170903, 9220904, 9220911, 9271003, 10140905, 10160902, 10211001, 11071104, 11091002, 12030902, 12080802, 12131002, 12281002, 12291010, LNR; c. Model Number CM-7111, Lot Codes: 2091006, 3151119, 3250808, 3291017, 4191103, 5181003, 5181013, 6211015, 7081014, 7131006, 7131007, 7140802, 7231006, 7281006, 7281021, 8161103, 8311128, 8311129, 8311130, 8311132, 9081006, 9091104, 9141014, 9220905, 9220912, 10140906, 10160804, 10160903, 10211011, 11091003, 12030903, 12131003, 12291009, LNR; d. Model Number CM-7129, Lot Codes: 1130905, 4211103, 6211012, 7010909, 7081015, 7231010, 7281007, 7281022, 7311214, 8041105, 8060804, 8161102, 8311140, 8311141, 8311142, 9081007, 9091105, 9170904, 9220906, 10211004, 12131004, 12291011, LNR; e. Model Number CM-7130, Lot Codes: 1130906, 3151120, 3291015, 5181010, 6211014, 7010910, 7081016, 7231007, 7281008, 7281023, 7311215, 8041106, 8060803, 8311135, 9081008, 9091106, 9170905, 9220907, 10211005, 12090903, 12131005, 12290912, 12291012, 90091106, LNR; f. Model Number CM-7131, Lot Codes: 1130907, 2111207, 3151121, 3291016, 4211102, 5181011, 6211016, 7010911, 7081017, 7231008, 7281009, 7311216, 8041107, 8060805, 8161101, 8221103, 8311136, 8311137, 8311138, 8311139, 9081009, 9091107, 9170906, 9220908, 10211010, 11090904, 11161015, 11171015, 12171118, 12290911, 12291013, LNR;
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated