CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report
Femoral Shaft L=; Femoral Shaft L= recalled
Stanmore Implants Worldwide is recalling Femoral Shaft L=; Femoral Shaft L=; Femoral Shaft L= The product is a component is a, 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
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-0822-2017
- 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
- Packaging Defects
- 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.
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
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm 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 AlabamaConnecticutFloridaLouisianaMarylandMississippiNebraskaNew YorkOhioPennsylvaniaTexas
Questions about this recall
Is Femoral Shaft L=; Femoral Shaft L=; Femoral Shaft L= The product is a component is a recalled?
Yes. Stanmore Implants Worldwide recalled Femoral Shaft L=; Femoral Shaft L=; Femoral Shaft L= The product is a component is a on 7 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-0822-2017.
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?
B10191, B10443, B9920, B10561, B9921, B9922
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 |
|---|---|---|---|---|---|
| Device | CLASS II | JTS External Drive Unit JTS Distal Femoral Extendible recalled | Stanmore Implants Worldwide | Other | 10 states |
| Device | CLASS II | Tibial Component Metal Cased Small Long recalled | Stanmore Implants Worldwide | Foreign Material | Nationwide |
| Device | CLASS II | DF Coated Integral Shaft & Stem 15x30x38 recalled | Stanmore Implants Worldwide | Packaging Defects | Nationwide |
| Device | CLASS II | Femoral Integral Shaft & Stem HA Coated recalled | Stanmore Implants Worldwide | Packaging Defects | Nationwide |
| Device | 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |