Z-0373-2019Class II

Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A -

Name: Z-0373-2019 Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A -
Creator: Howmedica Osteonics Corp.
Published: 2018-09-10
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2018-09-10 / Terminated / root cause: packaging

FDA source

Howmedica Osteonics Corp. began a recall of Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint... on 2018-09-10. FDA classified it as Class II and gives the reason as "Potential for outer pouch sterile barrier to be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0373-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-10
Posted: 2018-11-02
Terminated: 2020-08-31
Recalling firm: Howmedica Osteonics Corp
Product: Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee, shoulder, elbow or wrist arthroplasty, or trauma surgeries.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Potential for outer pouch sterile barrier to be compromised
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: All affected consignees were notified via 2-day UPS letter (with return receipt). The Urgent Product Recall notice was sent on September 11, 2018 and an updated version dated November 26, 2018 was distributed by Strykers third party recall company Stericycle. Actions to be Taken by Customer: 1. Please inform users of this Urgent Product Recall UPDATE and forward this notice to all those individuals who need to be aware within your organization. 2. Hospitals/Branches/Agencies: Complete and sign the enclosed Recall Notification Business Reply Form and fax a copy to 1-888-312-5960 or email to [email protected]
Quantity in commerce: 15 pouches
Distribution: US Nationwide in the states of AL, FL, IL, MI, NJ & OH.
Product codes and lots: Lot SC22130X Exp 2023-08-05

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0373-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0373-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)