Stryker GmbH Bohnackerweg 1 Selzach Switzerland Stryker End Cap T2 Humerus 6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker End Cap T2 Humerus 6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Brand
Stryker GmbH Bohnackerweg 1 Selzach Switzerland
Lot Codes / Batch Numbers
Lot Number: K037E2D
Products Sold
Lot Number: K037E2D
Stryker GmbH Bohnackerweg 1 Selzach Switzerland is recalling Stryker End Cap T2 Humerus 6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker imp due to Seal integrity of the blister pack may be compromised and sterility cannot be assured. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Recommended Action
Per FDA guidance
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 soprodexpreports@stryker.com. 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 StrykerOrtho8810@Stericycle.com. 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026