CLASS II Device recall · Reported 3 Dec 2014 · FDA Enforcement Report
Zimmer Patient Specific Instrument Persona CR Pin Guides recalled
Materialise USA is recalling Zimmer Patient Specific Instrument Persona CR Pin Guides (Femur and Tibia) is intended to, distributed nationwide in the US. The recall was initiated on 16 Oct 2014 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-0418-2015
- FDA event ID
- 69632
- Recalling firm
- Materialise USA, Plymouth, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Oct 2014
- FDA classified
- 21 Nov 2014
- Reported
- 3 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Nitrosamine Impurity
- Device type
- Hip & Knee Implants
Timeline
| 16 Oct 2014 | Recall initiated by company | |
| 21 Nov 2014 | Classified by FDA | +36 days |
| 3 Dec 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Where it was distributed
Nationwide Distribution to MN only
Questions about this recall
Is Zimmer Patient Specific Instrument Persona CR Pin Guides (Femur and Tibia) is intended to recalled?
Yes. Materialise USA recalled Zimmer Patient Specific Instrument Persona CR Pin Guides (Femur and Tibia) is intended to on 16 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0418-2015.
Why was it recalled?
The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
Which lots are affected?
00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902
Where was it sold?
Nationwide Distribution to MN 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 Materialise USA
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ProPlan CMF Anatomical recalled by Materialise USA | Materialise USA | Other | Nationwide |
| Device | CLASS II | Signature TKA GDE/MDL Set 04-05 Patient-specific surgical recalled | Materialise USA | Device Malfunction | IN |
| Device | CLASS II | REF 42-411571 QTY 1 Catalog Caution. SEE Instructions FOR USE recalled | Materialise USA | Sterility | MO |
| Device | CLASS II | ProPlan CMF Guide(s) recalled by Materialise USA | Materialise USA | Other | MI |
| Device | CLASS II | ProPlan CMF Guide(s) recalled by Materialise USA | Materialise USA | Other | MI |
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 |