Z-2386-2020Class II

Stryker Locking Screw, Fully Threaded T2 Tibia 5x50 mm Catalog Number: 18965050S -

Name: Z-2386-2020 Stryker Locking Screw, Fully Threaded T2 Tibia 5x50 mm Catalog Number: 18965050S -
Creator: Stryker GmbH
Published: 2020-05-07
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2020-05-07 / Terminated / root cause: manufacturing process

FDA source

Stryker GmbH began a recall of Stryker Locking Screw, Fully Threaded T2 Tibia 5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the... on 2020-05-07. FDA classified it as Class II and gives the reason as "Seal integrity of the blister pack may be compromised and sterility cannot be assured". 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-2386-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-07
Posted: 2020-06-16
Terminated: 2023-09-21
Recalling firm: Stryker Corp.
Product: Stryker Locking Screw, Fully Threaded T2 Tibia 5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker issued Urgent Medical Device Recall (UMDR) - PFA 2365134 letter on May 7, 2020 to affected US consignees by third-party recall company, Stericycle Inc. (2670 Executive Drive Indianapolis, IN 46241), via UPS 2nd day air. An OUS customer letter will also be issued at the country level The letter states reason for recall, heath risk and action to take: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list is at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. Return the devices back to Stryker. 4. Under 21 CFR 803, manufactures are also required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by emailing [email protected]. 5. A response is required, even though you may not have any physical inventory on site anymore. 6. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-888-912-8457 or email to [email protected]. 7. Hospitals Only: Please contact your Local Sales Office or your Stryker Sales Representative directly for product returns and inventory questions. 8.Branches/Agencies Only: Return all affected devices available at your location to the following address. Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive, Dock M-East Mahwah, NJ 07430 Ref. PFA 2365134 Questions or concerns after reviewing the letter, please contact Customer Service at (201) 831-5000.
Quantity in commerce: OUS 121
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
Product codes and lots: Lot Number: K030F1E, K033442

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2386-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2373-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2374-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2375-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2376-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2377-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2378-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2379-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2380-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2381-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2382-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2383-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2384-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2385-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2386-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2387-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16

Product code HSB

K032244Class IIGamma 3 Nail SystemHowmedica Osteonics Corp. / cleared 2003-08-08

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)