Z-1385-2023Class II

stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee...

Name: Z-1385-2023 stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee...
Creator: Howmedica Osteonics Corp.
Published: 2023-03-10
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2023-03-10 / Open, Classified

FDA source

Howmedica Osteonics Corp. began a recall of stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure on 2023-03-10. FDA classified it as Class II and gives the reason as "Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1385-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-10
Posted: 2023-04-12
Recalling firm: Howmedica Osteonics Corp
Product: stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Reason for recall: Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
FDA root cause: Process change control
Action: Stryker issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/10/2023 by letter. The notice explained the issue and the hazard and requested the following actions be taken: 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 affected products in Table 1. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to [email protected]/ fax (888) 266-7910. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return ALL affected product to: Stryker Orthopaedics/PFA Product Return. Stryker issued an URGENT MEDICAL DEVICE RECALL UPDATE notice to its consignees on 04/12/2023. The letter contained the same information, but added a section titled Recommendations for patients already treated with an affected device, and advised patients treated with an affected product should continue to be followed per the normal protocol established by his or her surgeon(s).
Quantity in commerce: 52 units
Distribution: U.S., Netherlands, Japan, China, India, Korea, and Australia.
Product codes and lots: GTIN 00848486003746, Lot Number 26270421

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1385-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1385-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1386-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12

Product code HSX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)