Z-1020-2017Class II

Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an...

Name: Z-1020-2017 Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2016-12-02
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2016-12-02 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system... on 2016-12-02. FDA classified it as Class II and gives the reason as "Reunion TSA Peg Alignment Sound broke during surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1020-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-02
Posted: 2017-01-12
Terminated: 2018-08-01
Recalling firm: Howmedica Osteonics Corp
Product: Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to final implantation into the glenoid vault. Its purpose is to provide assurance that the drilled holes for seating of the Glenoid implant have been properly prepared using the provided instrumentation
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Reunion TSA Peg Alignment Sound broke during surgery.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker Orthopaedics sent an Urgent Medical Device Recall Notification letter dated December 2, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to inform users of the Urgent Medical Device Recall and forward the notice to all those individuals who need to be aware within their organization. Return all affected products available to: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07431 1360184/RA2016-112 Complete and sign the enclosed Business Reply Form and fax a copy to 855-261-3635 or email to [email protected]. Customers with questions were instructed to call 201-831-6693.
Quantity in commerce: 131 units
Distribution: Nationwide Distribution
Product codes and lots: Catalog #5901-1038

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1020-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1020-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)