Z-1237-2026Class II

TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318

Name: Z-1237-2026 TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Creator: Tornier, Inc
Published: 2025-12-19
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2025-12-19 / Open, Classified / root cause: labeling and UDI

FDA source

Tornier, Inc began a recall of TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318 on 2025-12-19. FDA classified it as Class II and gives the reason as "A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1237-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-19
Posted: 2026-02-02
Recalling firm: TORNIER Inc.
Product: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On December 19, 2025, the firm began notifying affected customers via Urgent Field Safety Notice letters. Customers were instructed to immediately check their internal inventory for affected product. Firm stated that return of product is not necessary because the issue is detectable pre-operatively. The physical product itself is correctly marked, and after unpacking, should only be assigned to the correct place in the screw caddy. The notification is being provided for awareness only.
Quantity in commerce: 427
Distribution: US Nationwide distribution.
Product codes and lots: Lot AZ4824290

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1237-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1237-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-02

Product code KWS

K161742Class IIAequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. / cleared 2016-11-15

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)