Z-1045-2023Class II

MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008

Name: Z-1045-2023 MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-12-22
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-12-22 / Open, Classified / root cause: design

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008 on 2022-12-22. FDA classified it as Class II and gives the reason as "The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1045-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-22
Posted: 2023-02-01
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
Product code: KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque.
Root cause tag: design
FDA root cause: Device Design
Action: Medline issued a MEDICAL DEVICE RECALL notice to its direct consignees on 01/05/2023 by US mail and its distributors on 01/07/2023 by email. The notice explained the problem and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected items. Quarantine all affected product. All consignment inventory will be addressed by your local Medline UNITE Sales Representative. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the response form. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, LP. FURTHER ACTION: Medline is immediately recommending the use of our 1.6mm pre-drill for 2.0mm screws, and our 1.9mm pre-drill for the use of our 2.4mm screws and 2.7mm screws. If you have any questions, please contact 866-359-1704."
Quantity in commerce: 420 units
Distribution: US Nationwide distribution.
Product codes and lots: GTIN 10193489120387, Lot Number 810304

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1045-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1045-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-02-01
Z-1046-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-02-01
Z-1047-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-02-01

Product code KRR

K181280Class IIPatello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. / cleared 2018-06-14

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)