Z-1862-2011

Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K2399PR10; Stryker...

Name: Z-1862-2011 Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K2399PR10; Stryker...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2011-01-27
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2011-01-27 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K2399PR10; Stryker Howmedica Osteonics, Howmedica Osteonics Corp., 325... on 2011-01-27. The reason FDA records is "Stryker Orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus allowing for the reamer to leave as little as 8.9mm (in a nominal condition) patella bone". 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-1862-2011
Status: Terminated
Initiated: 2011-01-27
Posted: 2011-03-31
Terminated: 2012-10-15
Recalling firm: Howmedica Osteonics Corp
Product: Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00, I-K2399PR10; Stryker Howmedica Osteonics, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 The Xcelerate patella milling system (as detailed in surgical protocol LSPK35) was designed to prepare a patella to accept all Scorpio or Duracon patellar implants using either a resurfacing or recessed technique.
Product code: HTJ Gauge, Depth
Reason for recall: Stryker Orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus allowing for the reamer to leave as little as 8.9mm (in a nominal condition) patella bone.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker sent an Urgent Product Recall letter dated January 27, 2011, via FedEX for January 28, 2011, delivery with return receipt. The letter identified the product, the problem, and the action to be taken by the customer. Customers were insructed to fax back the attached Product Recall Acknowledgement Form within 5 days to 201-831-6069. Customers were also instructed to contact the hospitals in their territory that have the affected product to arrange return of the product. Product should be returned to the attention of: Regulatory Compliance Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey, 07430. The orange Product Remediation sticker should be attached to the return, indicating the Product Remediation # RA 2009-296. Mark the outer box with words "Product Recall." For questions regarding this recall call (201) 972-2100.
Quantity in commerce: 52 units
Distribution: Nationwide Distribution
Product codes and lots: All lots

Product code HTJ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)