Howmedica Osteonics Corp. Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00; Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Brand
Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Catalog Number: C-MM100434-00, Lot Number: HX2H9A
Products Sold
Catalog Number: C-MM100434-00; Lot Number: HX2H9A;
Howmedica Osteonics Corp. is recalling Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Cat due to A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
Recommended Action
Per FDA guidance
On August 5, 2024 an URGENT MEDICAL DEVICE RECALL letter was sent to their consignee. Actions Needed: Our records indicate that you have received the affected product, and that product has already been returned to Stryker. We therefore request that you read this notice carefully and complete the following actions. 1. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form. Please assist us in meeting our regulatory obligation by emailing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. We regret any inconvenience this action may cause. For questions pertaining to the recall, please email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
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