CLASS II Device recall · Reported 12 Aug 2020 · FDA Enforcement Report
Mako Hip End Effector, Variable Angle recalled by Mako Surgical
Mako Surgical is recalling Mako Hip End Effector, Variable Angle, distributed in 8 states. The recall was initiated on 9 Jul 2020 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-2745-2020
- FDA event ID
- 86048
- Recalling firm
- Mako Surgical, Davie, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jul 2020
- FDA classified
- 31 Jul 2020
- Reported
- 12 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 9 Jul 2020 | Recall initiated by company | |
| 31 Jul 2020 | Classified by FDA | +22 days |
| 12 Aug 2020 | 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
Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
Product as listed by the FDA
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Where it was distributed
TX, MN, CA, RI, FL, NY, AZ, TN
ArizonaCaliforniaFloridaMinnesotaNew YorkRhode IslandTennesseeTexas
Questions about this recall
Is Mako Hip End Effector, Variable Angle recalled?
Yes. Mako Surgical recalled Mako Hip End Effector, Variable Angle on 9 Jul 2020. The recall is Class II and its status is Terminated. Recall number Z-2745-2020.
Why was it recalled?
Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
Which lots are affected?
UDI: (01)00848486022167(21)1905386; (01)00848486022167(21)1905389; (01)00848486022167(21)1905359; (01)00848486022167(21)1905352; (01)00848486022167(21)1905369; (01)00848486022167(21)1905387; (01)00848486022167(21)1905383; (01)00848486022167(21)1905353; (01)00848486022167(21)1905356; (01)00848486022167(21)1905357; (01)00848486022167(21)1905365; (01)00848486022167(21)1905388;
Where was it sold?
TX, MN, CA, RI, FL, NY, AZ, TN
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 Mako Surgical
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|---|---|---|---|---|---|
| Device | CLASS II | Stryker USB Converter, Polaris Spectra Camera recalled by Mako Surgical | Mako Surgical | Device Malfunction | AZ, IL |
| Device | CLASS II | Mako Integrated Cutting System (MICS) Handpiece recalled | Mako Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | 7 Degree Straight Sagittal Saw attachment recalled by Mako Surgical | Mako Surgical | Other | 13 states |
| Device | CLASS II | 7 Degree Angled Sagittal Saw attachment recalled by Mako Surgical | Mako Surgical | Other | 13 states |
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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 |