Z-2347-2023Class II
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting...
Waldemar Link GmbH & Co. KG / initiated 2023-07-03 / Open, Classified / root cause: design
Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or... on . FDA classified it as Class II and gives the reason as "Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2347-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Waldemar Link GmbH & Co. KG
- Product
- LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-116/00
- Product code
- LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Reason for recall
- Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- LinkBio Corp initiated Urgent Medical Device Recall Letter to US Distributors via email on July 6, 2023. Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. These trials are contained in the MP Monoblock instrument sets. The entire instrument set must be returned as part of this recall. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address, referencing QT 2023-238: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or [email protected] for any questions
- Quantity in commerce
- 24 units
- Distribution
- US Nationwide distribution.
- Product codes and lots
- UDI-DI: 04026575182107 Lot Numbers: B923003 B932050 C005075 C211010
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2345-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2346-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2347-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2348-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2349-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2350-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2351-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2352-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2353-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2354-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2355-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2356-2023 | Class II | Ongoing | Voluntary: Firm initiated |
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