CLASS II Device recall · Reported 1 Aug 2018 · FDA Enforcement Report

AperFix Femoral Implant Coring Removal Drill recalled by Cayenne Medical

Cayenne Medical is recalling AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral, distributed nationwide in the US. The recall was initiated on 28 Apr 2010 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa. 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;

Quantity recalled1,444 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2548-2018
FDA event ID: 80415
Recalling firm: Cayenne Medical, Scottsdale, AZ
Classification: Class II
Status: Terminated
Recall initiated: 28 Apr 2010
FDA classified: 25 Jul 2018
Reported: 1 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

28 Apr 2010	Recall initiated by company
25 Jul 2018	Classified by FDA	+3010 days
1 Aug 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution. US nationwide, Denmark, Finland, Malaysia, Netherlands, Poland, Switzerland, and Turkey.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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;

Where was it sold?

Worldwide distribution. US nationwide, Denmark, Finland, Malaysia, Netherlands, Poland, Switzerland, and Turkey.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Cayenne Medical

All 3

Reported	Class	Recall	Company	Reason	Where
8 Aug 2018Device	CLASS II	Drill (Fluted-Hard Bone), for Quattro Link, labeled as recalled	Cayenne Medical	Device Malfunction	36 states
18 Jul 2018Device	CLASS II	AperFix AM Femoral Implant recalled by Cayenne Medical	Cayenne Medical	Device Malfunction	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide