Stryker Orthopaedics Sterile Knee Instrument, Patella Cutter; Stainless Steel, Disposable; Howmedica Osteonics Corp., 32

FDA device recall Z-0529-2010 · posted 2009-12-15 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Disposable Patella Cutters - 30 mm (catalog number 8000-0030, lot V31257001) were packaged and labeled as 33 mm Disposable Patella Cutters (catalog number 8000-0033, lot V31257001 and vice versa.

Action taken

An "Urgent Product Recall" letter dated November 11, 2009 was sent to all affected Stryker branches, hospital risk management, hospital Chief or Orthopaedics and surgeons by Federal Express. The letter described the issue, potential hazards and risk mitigation factors and requested that the Recall Acknowledgement form be completed and returned. The Recall Acknowledgement form has information regarding the return of affected product to the firm. Direct questions to Stryker Orthopaedics by calling 1-201-831-5832.

Root cause

Labeling mix-ups

Status

Terminated

Product code

HTS

Quantity affected

12

Distribution

Nationwide Distribution (MA, NJ, FL, TN, OR and NY).

Date initiated

2009-11-11

Date posted

2009-12-15

Date terminated

2010-08-30

Location

Mahwah, NJ