Stryker Definition PM Femoral Hip Stem Recalled for PMMA Coating Cracking
Stryker Howmedica Osteonics is recalling 16,913 Definition PM Femoral Hip Stems due to potential cracking of the PMMA coating. The devices were distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a structural component (PMMA coating) of an implanted medical device. While no injuries are reported, the potential for cracking in a load-bearing implant represents a significant risk of harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 16,913 units of the Definition PM Femoral Hip Stem, catalog numbers 6265-3-099 through 6265-3-107. The recall is due to the potential for cracking of the Poly Methyl Methacrylate (PMMA) coating on the device. The PMMA premantle is an integral part of the design intended to align, centralize, and pressurize the stem within the femoral canal.
The affected devices were manufactured in Ireland and distributed nationwide. The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Patients who have had this specific hip stem implanted should contact their orthopedic surgeon to discuss the potential risk and determine if further evaluation or intervention is necessary. The recall notice does not provide specific consumer instructions beyond the identification of the affected catalog and lot numbers.
The recalled product
- Product
- Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 16,913
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Stryker Howmedica Osteonics Corp.
See all →- HighStryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk
FDA (Devices) · 2017-05-31
- SevereStryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage
FDA (Devices) · 2017-01-18
- ModerateStryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2016-12-28
- SevereStryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure
FDA (Devices) · 2016-11-16
- HighStryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor
FDA (Devices) · 2016-10-19
Same hazard · structural failure
See all →- High
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- ModerateStryker Triathlon Femoral Distal Augment Recalled for Packaging Label Errors
FDA (Devices) · 2013-05-29
- HighStryker Recalls Rejuvenate Modular Hip Stems and Necks
FDA (Devices) · 2012-08-01
- ModerateStryker Recalls Specific Hip Stems Due to Packaging Error
FDA (Devices) · 2014-04-09
- ModerateStryker Recalls Accolade II Hip Stems Due to Packaging Error
FDA (Devices) · 2013-12-18
- HighStryker Recalls ABG II Modular Hip Stems for Corrosion Risk
FDA (Devices) · 2012-08-01
- HighStryker Recalls PCA Acetabular Inserts Due to Regulatory Omission
FDA (Devices) · 2015-11-25