CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report
Mets Smiles Total Knee Replacement recalled
Stanmore Implants Worldwide is recalling Mets Smiles Total Knee Replacement, distributed in Alabama, Mississippi, Texas. The recall was initiated on 31 May 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-2553-2016
- FDA event ID
- 74403
- Recalling firm
- Stanmore Implants Worldwide, Borehamwood, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 May 2016
- FDA classified
- 17 Aug 2016
- Reported
- 24 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 31 May 2016 | Recall initiated by company | |
| 17 Aug 2016 | Classified by FDA | +78 days |
| 24 Aug 2016 | 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
The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation.
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
METS SMILES Total Knee Replacement
Where it was distributed
Directly distributed to TX, further distributed to AL and MS
Questions about this recall
Is Mets Smiles Total Knee Replacement recalled?
Yes. Stanmore Implants Worldwide recalled Mets Smiles Total Knee Replacement on 31 May 2016. The recall is Class II and its status is Terminated. Recall number Z-2553-2016.
Why was it recalled?
The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation.
Which lots are affected?
Catalogue Numbers: mkfp/Std5 and mkfp/Std10 Batch Numbers: B4311 and B5470
Where was it sold?
Directly distributed to TX, further distributed to AL and MS
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 | Femoral Shaft L=; Femoral Shaft L= recalled | Stanmore Implants Worldwide | Packaging Defects | 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 |
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 |