CLASS II Device recall · Reported 25 Nov 2015 · FDA Enforcement Report
Stryker PCA 10 Degree Hooded Acetabular Insert ID recalled
Stryker Howmedica Osteonics is recalling Stryker PCA 10 Degree Hooded Acetabular Insert ID, Part of the Howmedica PCA Total Hip, distributed in Virginia. The recall was initiated on 15 Oct 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0281-2016
- FDA event ID
- 72506
- Recalling firm
- Stryker Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Oct 2015
- FDA classified
- 17 Nov 2015
- Reported
- 25 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 15 Oct 2015 | Recall initiated by company | |
| 17 Nov 2015 | Classified by FDA | +33 days |
| 25 Nov 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612.
Product as listed by the FDA
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
Where it was distributed
Distribution to Virginia only.
Questions about this recall
Is Stryker PCA 10 Degree Hooded Acetabular Insert ID, Part of the Howmedica PCA Total Hip recalled?
Yes. Stryker Howmedica Osteonics recalled Stryker PCA 10 Degree Hooded Acetabular Insert ID, Part of the Howmedica PCA Total Hip on 15 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0281-2016.
Why was it recalled?
Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612.
Which lots are affected?
Catalog Number:Lot Number; 6299-8-403:23182601; 6299-8-469:19123701; 6299-8-525:29115601; 6299-8-525:22727301; 6299-8-581:17772401; 6299-8-581:28432001.
Where was it sold?
Distribution to Virginia only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Stryker Howmedica Osteonics
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|---|---|---|---|---|---|
| Device | CLASS II | Hoffmann LRF Safety Clip (Bone Transport Strut) recalled | Stryker Howmedica Osteonics | Other | Nationwide |
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| Device | CLASS II | LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile recalled | Stryker Howmedica Osteonics | Sterility | Nationwide |
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |