Stryker Howmedica Osteonics Corp. Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. Intended to determine proper anatomical orientation, selection, alignment and position of the acetabular and femoral components. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. Intended to determine proper anatomical orientation, selection, alignment and position of the acetabular and femoral components.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Lot Numbers: 969A01, 969A02, 969A03, 969A04, 969A05, 968B01, 968B02, 100126171-01 and samples.
Products Sold
Lot Numbers: 969A01, 969A02, 969A03, 969A04, 969A05, 968B01, 968B02, 100126171-01 and samples.
Stryker Howmedica Osteonics Corp. is recalling Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corpora due to The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discove. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that the vial was leaking
Recommended Action
Per FDA guidance
Stryker Orthopaedics issued an "Important Product Removal" letter dated September 11, 2007 via Federal Express informing consignees of the affected devices. The firm requested that users identify and return any affected product and account for product by returning a Product Accountability Form via fax. For further information, contact Stryker Orthopaedics at 1-201-831-5825.
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