CLASS II Device recall · Reported 26 Dec 2012 · FDA Enforcement Report
Pinnacle Cancellous Screw Packaging recalled by DePuy Orthopaedics
DePuy Orthopaedics is recalling Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector, distributed nationwide in the US. The recall was initiated on 28 Nov 2012 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-0569-2013
- FDA event ID
- 62764
- Recalling firm
- DePuy Orthopaedics, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Nov 2012
- FDA classified
- 19 Dec 2012
- Reported
- 26 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 28 Nov 2012 | Recall initiated by company | |
| 19 Dec 2012 | Classified by FDA | +21 days |
| 26 Dec 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle¿ Cancellous Screw due to an incorrect description on the label. The label description reads Pinnacle Cannulated Screw and should read Pinnacle Cancellous Screw.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton, labeled and shrink-wrapped. PINNACLE¿ CANCELLOUS Bone Screws are ancillary fixation devices used in total hip arthroplasties. These screws are used to secure PINNACLE ACETABULAR Shell implants to the acetabulum via screw holes designed in the shell. Intended Use: This product is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures.
Where it was distributed
Nationwide distribution: USA states of: GA, MA, MN, SC and VA.
Nationwide GeorgiaMassachusettsMinnesotaSouth CarolinaVirginia
Questions about this recall
Why was it recalled?
DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle¿ Cancellous Screw due to an incorrect description on the label. The label description reads Pinnacle Cannulated Screw and should read Pinnacle Cancellous Screw.
Which lots are affected?
Catalog number: 121708500 and Lot numbers: 227619, 227620, 227621, 227622, 227627, 227630, 227646, 227650, 227651, and 227656.
Where was it sold?
Nationwide distribution: USA states of: GA, MA, MN, SC and VA.
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 26 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 DePuy Orthopaedics
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|---|---|---|---|---|---|
| Device | CLASS II | Attune Affixium Cementless Fixed Bearing Knee recalled | DePuy Orthopaedics | Labeling Errors | Nationwide |
| Device | CLASS II | Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 recalled | DePuy Orthopaedics | Other | Nationwide |
| Device | CLASS II | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled | DePuy Orthopaedics | Other | Nationwide |
| Device | CLASS II | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled | DePuy Orthopaedics | Other | Nationwide |
| Device | CLASS II | Attune Revision Limb Preservation System (LPS) Tibial Insert SM recalled | DePuy Orthopaedics | Other | Nationwide |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |