Mako Hip End Effector Recalled for Potential Bone Preparation Discrepancy
Mako Surgical Corporation is recalling 12 units of Mako Hip End Effectors due to a characterization issue that may cause discrepancies during bone preparation in certain Mako Total Hip procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential discrepancy in a surgical procedure (bone preparation) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Mako Surgical Corporation is recalling 12 units of the Mako Hip End Effector, Variable Angle (Catalog Number: 206967). The recall is due to a characterization issue associated with the product.
This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures. The affected units were distributed to facilities in Texas, Minnesota, California, Rhode Island, Florida, New York, Arizona, and Tennessee.
Healthcare providers should stop using the affected devices and contact Mako Surgical Corporation for further instructions. Consumers are not directly affected as this is a professional medical device used in surgical procedures.
The recalled product
- Product
- Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
- Manufacturer
- Mako Surgical Corporation
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- 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
Distribution
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