Z-1247-2022Class II

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

Name: Z-1247-2022 GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Creator: Medacta Usa Inc
Published: 2022-04-13
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2022-04-13 / Terminated / root cause: manufacturing process

FDA source

Medacta Usa Inc began a recall of GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 on 2022-04-13. FDA classified it as Class II and gives the reason as "A Size 2 trial baseplate was assembled with Size 1 instrument sets". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1247-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-13
Posted: 2022-06-07
Terminated: 2023-10-23
Recalling firm: Medacta USA, Inc.
Product: GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm emailed their sales agents on 4/13/2022 to notify them the implants were associated with a recall and must be returned immediately to the recalling firm. It also said that replacements are currently on order and will be overnighted to them once they are available. A copy of the Field Safety Notice from the manufacturer was forwarded to the sales agents. The Notice informed them the three affected lots have been assembled following an incorrect packing list, resulting in a size 2 trial baseplate being inserted in a size 1 instrument set, and that all the other devices included in the packing list and instrument set are correct.
Quantity in commerce: 50 units
Distribution: Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
Product codes and lots: Model Number/Reference Code: 11.01041; UDI-DI: 07630971252509; Lot Numbers Lots: 2109258 (exp. 06/24/2026), 2111198 (exp. 10/04/2026), 2115530 (exp. 10/27/2026)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1247-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1247-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-15	2022-06-07

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)