CLASS II Device recall · Reported 5 Aug 2015 · FDA Enforcement Report

Medical Device Exchange Femoral Canal Tip recalled

EXP Pharmaceutical Services is recalling Medical Device Exchange Femoral Canal Tip, distributed in Arkansas, California, Colorado, District of Columbia, Florida, Texas. The recall was initiated on 11 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesOEM Catalog number 210-8-N.

Quantity recalled12

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-2231-2015
FDA event ID: 71608
Recalling firm: EXP Pharmaceutical Services, Fremont, CA
Classification: Class II
Status: Terminated
Recall initiated: 11 Feb 2015
FDA classified: 24 Jul 2015
Reported: 5 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

11 Feb 2015	Recall initiated by company
24 Jul 2015	Classified by FDA	+163 days
5 Aug 2015	Published in enforcement report	+12 days

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

Reason for recall

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 210-8-N; EXP (repackager), Stryker (OEM) Lavage, jet

Where it was distributed

Distributed in DC and the states of CO, CA, FL, TX, and AR.

Arkansas California Colorado District of Columbia Florida Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

OEM Catalog number 210-8-N.

Where was it sold?

Distributed in DC and the states of CO, CA, FL, TX, and AR.

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.

Other products in this recall event

41 other products · FDA event 71608

This product is part of a recall event; the main page for the event is Medical Device Exchange PT WIRE recalled by EXP Pharmaceutical Services.

Reported	Class	Recall	Company	Reason	Where
5 Aug 2015	CLASS II	Medical Device Exchange PT WIRE recalled by EXP Pharmaceutical Services	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for Crani recalled	EXP Pharmaceutical Services	Foreign Material	6 states
5 Aug 2015	CLASS II	Medical Device Exchange -Suction Coagulator recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Ets Flex 45 Endoscopic Articulating recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Securestrap Absorbable Strap Fixation Device recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Wire (sternotomy wire) recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Round Diamond Bur Extra Coarse recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Insufflation Needle recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange - Endo Catch recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange - Mayfield Disposable Skull Pin recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Threaded Cerclage Pin recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Airway Stent System recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange TAUT Intraducer Peritoneal Catheter x recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Vascular recalled by EXP Pharmaceutical Services	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange - Auto Suture Endo Universal recalled	EXP Pharmaceutical Services	Foreign Material	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Round Fluted Bur Soft Touch recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Angio-Seal VIP Platform/Vascular recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve recalled	EXP Pharmaceutical Services	Foreign Material	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Round Fluted Bur Aggressive recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange -System, Tacker Skin recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Fiberwire Suture Scissor recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange - BioComposite Corkscrew FT recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Vascular recalled by EXP Pharmaceutical Services	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange - Trocar VersaPort Plus V2 recalled	EXP Pharmaceutical Services	Foreign Material	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Airway Stent System recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange PhysioMesh Flexible Composite Mesh recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Round Fluted Bur Soft Touch recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange - GelPort Laparoscopic System recalled	EXP Pharmaceutical Services	Foreign Material	6 states
5 Aug 2015	CLASS II	Medical Device Exchange - Loading Unit w/ DST Series recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange - Kii Fios First Entry 5X100MM recalled	EXP Pharmaceutical Services	Foreign Material	6 states
5 Aug 2015	CLASS II	Medical Device Exchange - Versaport Bladeless Trocar w recalled	EXP Pharmaceutical Services	Foreign Material	6 states
5 Aug 2015	CLASS II	Medical Device Exchange - Silicone Round Drain recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Aerosizer Stent Sizing Device recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange Surgical Gown - Flyte Hood recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve recalled	EXP Pharmaceutical Services	Foreign Material	6 states
5 Aug 2015	CLASS II	Medical Device Exchange -Applier, Multiclip Rotating recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange, Specimen Retriever Endo recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange - GIA Auto Suture Loading Unit w recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange PhysioMesh Flexible Composite Mesh recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015	CLASS II	Medical Device Exchange X-saw Blade recalled	EXP Pharmaceutical Services	Packaging Defects	6 states

More recalls from EXP Pharmaceutical Services

All 42

Reported	Class	Recall	Company	Reason	Where
5 Aug 2015Device	CLASS II	Medical Device Exchange X-saw Blade recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015Device	CLASS II	Medical Device Exchange PhysioMesh Flexible Composite Mesh recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015Device	CLASS II	Medical Device Exchange - GIA Auto Suture Loading Unit w recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015Device	CLASS II	Medical Device Exchange, Specimen Retriever Endo recalled	EXP Pharmaceutical Services	Packaging Defects	6 states
5 Aug 2015Device	CLASS II	Medical Device Exchange -Applier, Multiclip Rotating recalled	EXP Pharmaceutical Services	Packaging Defects	6 states

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