Z-2909-2018Class II
QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
Stryker Leibinger GmbH & Co. KG / initiated 2018-06-22 / Terminated / root cause: packaging
Stryker Leibinger GmbH & Co. KG began a recall of QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium on . FDA classified it as Class II and gives the reason as "After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-2909-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Product
- QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
- Product code
- GWO Plate, Cranioplasty, Preformed, Alterable
- Reason for recall
- After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Root cause tag
- packaging
- FDA root cause
- Package design/selection
- Action
- URGENT MEDICAL DEVICE RECALL letters dated 6/22/18 were sent to customers with the following requested actions to be taken: 1. Please inform users of this Medical Device Removal and pass this notice to all appropriate individuals within your organization. 2. Return all affected products available at your location to: Stryker CMF Attn: Recall Coordinator 6300 Sprinkle Rd Portage, MI 49002 REF: PFA #1739180 Or, Contact Stryker Customer Service and refer to PFA #1739180 with any questions about returning the product to us. 3. Complete and sign the enclosed Business Reply Form and fax a copy to: (877) 648-7114 or email a copy to [email protected]. 4. Keep a copy of the completed and executed Customer response Form for your records.
- Quantity in commerce
- 22,831 total
- Distribution
- US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
- Product codes and lots
- 1000167017, 1000167829, 1000171360, 1000172321, 1000173866, 1000175689, 1000178993, 1000187364, 1000198471, 1000198472, 1000202431, 1000205662, 1000215879, 1000217675, 1000226524, 1000233194, 1000238414, 1000259405
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2898-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2899-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2900-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2901-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2902-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2903-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2904-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2905-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2906-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2907-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2908-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2909-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2910-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2911-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2912-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2913-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2914-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2915-2018 | Class II | Terminated | Voluntary: Firm initiated |
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