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RESTORIS recallZ-1386-2023 · Howmedica Osteonics Corp. · initiated Mar 10, 2023

Open, Classified

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

FDA root cause category: Process change control

What the company is doing

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).

Recall details

Recall number
Z-1386-2023
Status
Open, Classified
Initiated by the company
Mar 10, 2023
Posted by the FDA
Apr 12, 2023
Recalling firm
Howmedica Osteonics Corp.
Quantity
102 units
Product code
HSX
FDA submissions
K082172, K090763
Distribution
U.S., Netherlands, Japan, China, India, Korea, and Australia.

Product description

stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure

Code information (models, lots, serial numbers)

GTIN 00848486003753, Lot Number 26250421

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

67 devices cleared under K082172, K090763 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91913).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page