Mako Surgical Recalls Restoris Knee Implants Due to Packaging Damage
Mako Surgical Corporation is recalling 146 units of the Restoris Multicompartmental Knee System because damaged packaging may have compromised the sterile barrier.
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 compromised sterile barrier for an implant, which poses a risk of harm (infection) even though specific injuries are not reported in the source text.
Plain-English summary
Mako Surgical Corporation is recalling 146 units of the Restoris Multicompartmental Knee (MCK) System. The recall involves specific catalog numbers and lots of the Restoris MCK Baseplate in clamshell packaging configuration.
The recall was initiated because reports indicated that the Mylar/Tyvek pouches for the baseplate exhibited damage. This damage compromised the sterile barrier, which is critical for maintaining the sterility of the implant prior to surgical use.
The affected products were distributed worldwide, including nationwide in the United States and in Italy, Scotland, Turkey, Greece, Germany, and Singapore. Healthcare providers and patients who have received or used these specific lots should contact Mako Surgical Corporation for further instructions on how to proceed.
The recalled product
- Product
- Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
- Manufacturer
- Mako Surgical Corporation
- Affected units
- 146
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 (20)
- Catalog # 180601 - Lot #'s: 26110111
- 26300512-01
- 26110112-01
- and 26090311-01 Catalog # 180602 - Lot #'s: LET1484311012
- 26020812-01
- 26220512-01
- 26180711-0126120211-01
- 26301011-01
- 26161111-01
- and 26220512-02. Catalog # 180603 - Lot #'s: LET 1388860512
- 26010511-01
- 26270512-01
- and 26250511-01 Catalog # 180606 - Lot #'s: LET1464570912
- 26300412-01
- 26140412-01
- and 26050212-01. Catalog # 180607 - Lot #'s: 26211011-01
- 26040212-01
- 26330512-01
- 26090611-02
- 26070811-01
Distribution
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