Mako Hip End Effector, Variable Angle recallZ-2745-2020 · Mako Surgical Corporation · initiated Jul 9, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mako Surgical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
FDA root cause category: Under Investigation by firm
What the company is doing
On July 09, 2020, Stryker's issued urgent medical device recall. The following actions were instructed in the recall notification. 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3.Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. 4.Hospitals/Branches/Agencies: Complete and sign the Urgent Medical Device Recall Business Reply Form and fax a copy to 1-888-528-4543 or email to [email protected]. 5.Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 6.Branches/Agencies Only: Please forward the Urgent Medical Device Recall to the individuals or organizations who have consigned product, if applicable. Return all affected devices available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 2390692
Recall details
- Recall number
- Z-2745-2020
- Status
- Terminated
- Initiated by the company
- Jul 9, 2020
- Posted by the FDA
- Jul 31, 2020
- Recalling firm
- Mako Surgical Corporation
- Quantity
- 12 units
- Product code
- OLO
- FDA submissions
- K141989
- Distribution
- TX, MN, CA, RI, FL, NY, AZ, TN
Product description
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Code information (models, lots, serial numbers)
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;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA 206967Mako Surgical Corp. · Orthopedic stereotaxic instrument1 recall29 reports
Other devices under the same FDA submission
3 devices cleared under K141989 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- TRIDENT, RIO 209830Mako Surgical Corp. · Orthopedic stereotaxic instrument35 reports
- TRIDENT, RIO 209820Mako Surgical Corp. · Orthopedic stereotaxic instrument11 reports
- NA 204980Mako Surgical Corp. · Orthopedic stereotaxic instrument2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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