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U.S. Department of Health and Human Services

Class 2 Device Recall AperFix Femoral Implant Coring Removal Drill

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  Class 2 Device Recall AperFix Femoral Implant Coring Removal Drill see related information
Date Initiated by Firm April 28, 2010
Create Date July 25, 2018
Recall Status1 Terminated 3 on February 26, 2019
Recall Number Z-2548-2018
Recall Event ID 80415
Product Classification Reamer orthopedic surgical instrument - Product Code HTO
Product 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.
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;  
Recalling Firm/
Manufacturer		 Cayenne Medical Inc.
16597 N 92nd St Ste 101
Scottsdale AZ 85260-1847
For Additional Information Contact Kevin Escapule
574-372-4487
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
Action Customers were contacted via email on approximately 10/10/2013 and were instructed to return any affected products on hand.
Quantity in Commerce 1,444 units total
Distribution Worldwide distribution. US nationwide, Denmark, Finland, Malaysia, Netherlands, Poland, Switzerland, and Turkey.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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