CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report

Tibial Component Metal Cased Small Long recalled

Stanmore Implants Worldwide is recalling Tibial Component Metal Cased Small Long, distributed nationwide in the US. The recall was initiated on 7 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesA10337, A11525, A7823, A9990, A11289, A11979, A12134, A7186, A8679, A9743, A10344, A10629, A10791, A10348a, A11198, A11557, A11895, A12090, A12129, A12220, A12223, A12229

Quantity recalled51 units

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-0821-2017
FDA event ID: 75892
Recalling firm: Stanmore Implants Worldwide, Borehamwood, N/A
Classification: Class II
Status: Terminated
Recall initiated: 7 Dec 2016
FDA classified: 19 Dec 2016
Reported: 28 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Hip & Knee Implants

Timeline

7 Dec 2016	Recall initiated by company
19 Dec 2016	Classified by FDA	+12 days
28 Dec 2016	Published in enforcement report	+9 days

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

Reason for recall

The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone

Where it was distributed

Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

Nationwide Alabama Connecticut Florida Louisiana Maryland Mississippi Nebraska New York Ohio Pennsylvania Texas

Questions about this recall

Is Tibial Component Metal Cased Small Long recalled?

Yes. Stanmore Implants Worldwide recalled Tibial Component Metal Cased Small Long on 7 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-0821-2017.

Why was it recalled?

The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.

Which lots are affected?

A10337, A11525, A7823, A9990, A11289, A11979, A12134, A7186, A8679, A9743, A10344, A10629, A10791, A10348a, A11198, A11557, A11895, A12090, A12129, A12220, A12223, A12229

Where was it sold?

Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

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 21 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 Stanmore Implants Worldwide

All 8

Reported	Class	Recall	Company	Reason	Where
13 Sep 2017Device	CLASS II	JTS External Drive Unit JTS Distal Femoral Extendible recalled	Stanmore Implants Worldwide	Other	10 states
28 Dec 2016Device	CLASS II	Femoral Shaft L=; Femoral Shaft L= recalled	Stanmore Implants Worldwide	Packaging Defects	Nationwide
28 Dec 2016Device	CLASS II	DF Coated Integral Shaft & Stem 15x30x38 recalled	Stanmore Implants Worldwide	Packaging Defects	Nationwide
28 Dec 2016Device	CLASS II	Femoral Integral Shaft & Stem HA Coated recalled	Stanmore Implants Worldwide	Packaging Defects	Nationwide
28 Dec 2016Device	CLASS II	Tibial Component Fixed Hinge Small Long recalled	Stanmore Implants Worldwide	Packaging Defects	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	Nitrosamine Impurity	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)	Lead & Heavy Metals	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide